MAKOplasty®

Location:

Ft. Lauderdale, FL

Position Description:

The Application System Engineer will develop the analysis, documentation and test of the integration of system components (software, robotic arm, implants, and surgical instruments) to deliver best-in-class robotic-assisted orthopedic solutions.  The Application System Engineer will work in close collaboration with the engineering, marketing, quality assurance and program management groups to deliver the product development roadmap and improve quality, clinical value, OR efficiency, and customer satisfaction for MAKO customers. Furthermore, the Application System Engineer will support the continuous improvement of MAKO's product development tools and processes.  

Responsibilities:

• Designs/Involves in the “Design & Development” of system features with the software, Robotic Platform, implants, and surgical instruments of new and existing medical device/equipment products:
• Develops & writes specifications, flow- down specifications to sub-systems team(s), 
• Develops & writes tests protocols,
• Develops & plans Systems Integration steps for the design & development of features of the RIO MAKO Application (software, Robotic Platform, implants, and surgical instruments)
• Analysis of the system feature:  purpose, scope, risks, targets, Gage R&R, DOE, statistical analysis, to support the flow-down of the systems, verification & validation.
• Conducts product testing and create models and prototypes. 
• Troubleshoots the systems aspects of features implemented and proposed solutions. 
• Executes assigned systems protocols, and writes the test results report. Participates in design review & verifications report review.
• Provide status updates on projects to Project Lead and/or Application System Director
• May be required to participate in R&D departmental policies and procedure updates.

Qualifications:

• Bachelor’s degree in an engineering discipline (or related science) with a minimum of 2 years technical experience in the design of medical systems. Master ‘s degree preferred in an engineering discipline (or related science)  
• Knowledge in “Systems Engineering” applied to medical devices.  
• Knowledge of Software Tools for statistical analysis.
• Knowledge of Matlab, Minitab, 3D CAD softwares (Solidworks)
• Knowledge of requirements, specifications  systems process 
• Excellent communication, reporting, and documentation skills
• Experience designing systems applied to medical equipment  
• Must be extremely detail oriented with strong written, verbal, interpersonal, computer, and organizational skills

Location:

Ft. Lauderdale, FL

Position Description:

The Application System Engineer will develop the analysis, documentation and test of the integration of system components (software, robotic arm, implants, and surgical instruments) to deliver best-in-class robotic-assisted orthopedic solutions.  The Application System Engineer will work in close collaboration with the engineering, marketing, quality assurance and program management groups to deliver the product development roadmap and improve quality, clinical value, OR efficiency, and customer satisfaction for MAKO customers. Furthermore, the Application System Engineer will support the continuous improvement of MAKO's product development tools and processes.  

Responsibilities:

• Designs/Involves in the “Design & Development” of system features with the software, Robotic Platform, implants, and surgical instruments of new and existing medical device/equipment products:
• Develops & writes specifications, flow- down specifications to sub-systems team(s),
• Develops & writes tests protocols,
• Develops & plans Systems Integration steps for the design & development of features of the RIO MAKO Application (software, Robotic Platform, implants, and surgical instruments)
• Analysis of the system feature:  purpose, scope, risks, targets, Gage R&R, DOE, statistical analysis, to support the flow-down of the systems, verification & validation.
• Conducts product testing and create models and prototypes.
• Troubleshoots the systems aspects of features implemented and proposed solutions.
• Executes assigned systems protocols, and writes the test results report. Participates in design review & verifications report review.
• Provide status updates on projects to Project Lead and/or Application System Director
• May be required to participate in R&D departmental policies and procedure updates.

Qualifications:

• Bachelor’s degree in an engineering discipline (or related science) with a minimum of 2 years technical experience in the design of medical systems. Master ‘s degree preferred in an engineering discipline (or related science)  
• Knowledge in “Systems Engineering” applied to medical devices.  
• Knowledge of Software Tools for statistical analysis.
• Knowledge of Matlab, Minitab, 3D CAD softwares (Solidworks)
• Knowledge of requirements, specifications  systems process
• Excellent communication, reporting, and documentation skills
• Experience designing systems applied to medical equipment 
• Must be extremely detail oriented with strong written, verbal, interpersonal, computer, and organizational skills

Location:

Ft. Lauderdale, FL

Position Description:

The Application System Engineer will develop the analysis, documentation and test of the integration of system components (software, robotic arm, implants, and surgical instruments) to deliver best-in-class robotic-assisted orthopedic solutions.  The Application System Engineer will work in close collaboration with the engineering, marketing, quality assurance and program management groups to deliver the product development roadmap and improve quality, clinical value, OR efficiency, and customer satisfaction for MAKO customers. Furthermore, the Application System Engineer will support the continuous improvement of MAKO's product development tools and processes.  

Responsibilities:

• Designs/Involves in the “Design & Development” of system features with the software, Robotic Platform, implants, and surgical instruments of new and existing medical device/equipment products:
• Develops & writes specifications, flow- down specifications to sub-systems team(s),
• Develops & writes tests protocols,
• Develops & plans Systems Integration steps for the design & development of features of the RIO MAKO Application (software, Robotic Platform, implants, and surgical instruments)
• Analysis of the system feature:  purpose, scope, risks, targets, Gage R&R, DOE, statistical analysis, to support the flow-down of the systems, verification & validation.
• Conducts product testing and create models and prototypes.
• Troubleshoots the systems aspects of features implemented and proposed solutions.
• Executes assigned systems protocols, and writes the test results report. Participates in design review & verifications report review.
• Provide status updates on projects to Project Lead and/or Application System Director
• May be required to participate in R&D departmental policies and procedure updates.

Qualifications:

• Bachelor’s degree in an engineering discipline (or related science) with a minimum of 2 years technical experience in the design of medical systems. Master ‘s degree preferred in an engineering discipline (or related science)  
• Knowledge in “Systems Engineering” applied to medical devices.  
• Knowledge of Software Tools for statistical analysis.
• Knowledge of Matlab, Minitab, 3D CAD softwares (Solidworks)
• Knowledge of requirements, specifications  systems process
• Excellent communication, reporting, and documentation skills
• Experience designing systems applied to medical equipment 
• Must be extremely detail oriented with strong written, verbal, interpersonal, computer, and organizational skills

Location:

Ft. Lauderdale, FL

Position Description:

The Product Development Engineer for the Biomechanics team participates in the design and development of implant or implant or bone related instruments and projects from concept to product launch using his/her experience in human body biomechanics, medical device industry requirements, time management, and design controls.

Departmental Responsibilities:

• Work under the guidance of experienced technical team to design and develop new orthopedic implants and instrumentation and make improvements and modifications to current products.
• Contribute to several engineering projects consisting of design, prototype development and testing through successful transition to manufacturing and product launch. Independently apply sound engineering problem solving techniques to these projects including design, analysis, material selection, inspection and manufacturing requirements.
• Manage individual time to meet the time commitments of multiple tasks of a project and ensure timely completion of accurate and high quality deliverables that support the needs of the project team.
• Execute specified requirements definition, risk analysis, verification, validation, and design transfer processes for all products as assigned from the program or functional team leaders.
• Contribute to the content of design history files and document deliverables to ensure compliance with FDA and international regulatory agencies design control regulations.
• Provide technical support for marketing and sales such as design rationale, surgical technique, sales sheets, specification guides, computer animations, and presentations.
• Generate implant and instrumentation CAD models and detailed drawings using SolidWorks software, maintain design history of models and drawings per the MAKO quality system.
• Develop mechanical test protocols according to external and internal standards, obtain test parts, design test fixtures and complete mechanical testing at MAKO Surgical Corp. and/or outside testing laboratories then document all findings in the appropriate test reports.
• Interact with Product Management/Marketing/Sales and Quality (where appropriate) to obtain feedback on new product designs and necessary changes to existing designs.
• Seek opportunities to learn and gain familiarity and expertise in specific technical skills such as finite element analysis, conducting efficient tolerance analysis or specific advanced 3D modeling techniques by partnering with subject matter experts and through independent study.
• Uphold MAKO’s Quality Policy
• Assist in preparing invention disclosures and patent applications.
• Assist the Phase 0 team as needed with prototype design, concepts or testing.
• Understand clinical issues, define design parameters, and ensure that the correct product is provided to the customer.
• Travel as necessary for project design meetings, support of sales and marketing activities, and professional meetings.

Qualifications:

• Bachelor’s Degree in Mechanical, Biomedical Engineering or equivalent engineering field
• 5+ years of experience in the field of orthopedic or spine implants product design and development
• A high level of CAD and Microsoft Office and Microsoft Project proficiency is required
• Self-driven, creative, and strong problems solving skills
• Superior written and spoken English communication, reporting, documentation, and organizational skills

Location:

Ft. Lauderdale, FL

Position Summary

The System Administrator is responsible for partnering with the Engineering, Quality, and Operations organization, working to understand and improve the requirements management applications in place to support the organization. Primary responsibility will be to work closely with the stakeholders to administer the system and capture user requirements, define business processes, and design, test, and implement software solutions that meet the business' needs.

Responsibilities:

• Suggest and develop features for the organizations requirements management application implementation
• Write documentation and work instructions requirements management application.
• Provide training to the users of the requirements management application.
• Conduct iterative requirements sessions with the stakeholders to define functional system requirements via workshops, use cases, scenarios and other methods.
• Analyze, document and test program development, logic, process flows and specifications.
• Partner with stakeholders to conduct user acceptance testing.
• Establish and enforce proper change request management procedures to ensure proper scope control.
• Communicate changes, enhancements, and modifications – verbally or through written documentation to stakeholders, and sponsors so that issues and solutions are understood.
• Complete implementation and migration of upgrades, patches, code releases and database changes.
• Create and maintain documentation of existing system configurations.
• Ensure that solutions are error-free and well tested, meeting user requirements.
• Other duties as assigned.

Requirements

• Bachelor's degree in Computer Science or related field with minimum of 1 - 3 years of experience installing, implementing, and supporting business applications in a Windows-based environment.
• Linux system administration experience. Preferred SUSE Enterprise Linux system administration and/or Ubuntu/Debian Linux system administration
• Strong scripting skills with JavaScript language
• Experience with web development
• Experience with Java programming language
• Exposure to MSSQL Server databases
• Experience with SQL databases
• Experience working with VMware virtual servers
• Strong analytical skills applied to understanding business functionality and translating them into application requirements.
• Demonstrated experience in writing software requirements and test specifications.
• Experience with Project Management and methodologies for successful product delivery.
• Possess strong problem solving skills and customer service attitude and focus. Be able to follow-up with managers, peers, and customers on all projects and efforts.
• A motivated self-starter that is able to work independently and in teams on tasks and projects with limited supervision.
• Capable of multi-tasking, working within deadlines, and possess a strong aptitude for learning.
• Excellent analytical/troubleshooting skills.
• Must have excellent oral, written and interpersonal communication skills.

Reno, NV Louden, VA

Position Description

This is an exciting and rewarding career pathway into the world of surgical technology and device sales. This employee provides clinical and technical support to product end users during surgical procedures that involve the use of a surgeon interactive robotic system and the implantation of partial and total joint implants.

This individual will develop and maintains high quality relationships with hospital staff and surgeon users and continuously promotes the use of the company’s technologies and devices to all potential new surgeon customers.

Primary Responsibilities

• Provides surgeons, operating room and hospital staff with training and Clinical/Technical support in the operation of the company’s robotic arm applications, associated equipment and instruments to insure ideal placement and precision.
• Uses proprietary software to prepare pre-operative CT scans for use in conjunction with the company’s RIO^® Robotic Arm Interactive Orthopedic System, assists surgeon in preoperative implant planning, implant sizing and positioning.
• Obtains purchase orders for products consumed during surgical procedures.
• Provides complete reports and associated metrics to management, direct supervisor and company’s regulatory department detailing case reviews, services performed and recommendations for product, documentation and methodology improvements.
• Maintains and controls local MAKO consigned equipment, instrument, implant and disposables inventories, processes sales orders and provides forecast input to Sales Management.
• Supports company road-show demonstrations and ‘Show-site’ visits.
• Acts as an advocate with the company to solve any customer issues or complaints.

Additional Responsibilities

• At the direction of the Senior MAKOplasty Specialist supports the development and execution of a sales plan to grow the utilization of the RIO system and implant sales.
• Actively sell the clinical benefits of the products, and build strong, positive relationships with key surgeons and OR staff at targeted accounts.
• Collaborates with Senior MAKOplasty Specialists and Marketing to increase public awareness.
• Must attend a rigorous training course and be certified to be able to be able to support the customers safe and effective use of the products.

Qualifications/Requirements

• Bachelor’s degree with a minimum of 1 year of sales or sales/customer support experience.
• Demonstrated track record of success and leadership in business, school, athletics and other venues.
• Experience in the clinical environment, in particular orthopedics a SIGNIFICANT plus.
• Demonstrated enthusiasm for new technology and ability to understand it.
• Ability to work in a team oriented environment with excellent interpersonal and communication skills.
• Ability to operate a PC and use Windows based software.
• Must have and maintain a current driver’s license.
• Travel may vary from 25% to 75% depending on business needs.

Indiana/Ohio New York City

Position Description:

• Develops and maintains outstanding relationships with the company's prospective and installed base customers, and leverages relationships to drive recurrent sales cycles for the company's products.
• Identifies, qualifies and cultivates new sales opportunities and effectively manages leads generated by the company.
• Leads a cross functional team in executing the sales cycle, as well as post sale installation and training activities at customer site
• Transitions "ownership" of account to MAKO Regional Account Managers.
• Demonstrated ability to build, and manage, a "funnel" of capital sales opportunities sufficient to insure that annual quotas are met or exceeded.
• Demonstrated ability to manage, and close capital sales cycles for products that sell for greater than $800,000
• Demonstrated ability to sell a breakthrough technology, and establish a new marketplace.
• Must be effective in partnering with marketing and sales management to build the strategies and selling tools that will further support increased selling effectiveness.
• Demonstrated ability to move sales through a budgeted and more importantly, an off budget process.
• Comfortable and facile with the use of financing and leasing products to close business

Departmental Responsibilities:

• Departmental Responsibilities
• Consistently meets or exceed sales target
• Consistently meets or exceeds budget goal
• Provides consistent and timely reporting of sales opportunities, lead follow up and forecasts and other reporting as require
• Provides senior leadership to cross functional teams members who support the selling and post sale activities at the account
• Attends sales training meetings, as well as trade shows and other events that would tend to promote and give visibility to the companies' products

Qualifications:

• BA/BS
• 5+ years demonstrated level of achievement in Surgical or Medical capital equipment sales.
• Demonstrated ability to interact intelligently, and with credibility, with surgeons and allied healthcare professionals
• Demonstrated ability to translate clinical benefits of products to economic value to the health care provider and is comfortable with financial based selling tools
• Experience in surgical orthopedics highly desirable.
• Demonstrated ability to manage large territory.
• Outstanding presentation and communication skills, verbal and written.
• 75% plus travel required.
• Executive selling experience background. (CEO/CFO/COO of hospitals)
• An understanding of the financial operations of hospitals

****You must live within in 30 miles of a major airport.****

Location:

Ft. Lauderdale, FL

Position Description:

Segmentation Specialist will receive DICOM CT files from field based personnel (internal and/or customer sites) and segment those files, as well as pre-plan the surgical positioning of MAKO Implants.   These files will be uploaded back onto the DEW server as a session file ready for the field based personnel to download for MAKOplasty cases.

Responsibilities:

Segment and pre-plan DICOM files intended for use in MAKOplasty procedures (100%)

Qualifications:

• HS Diploma with a minimum of 5 years work experience in corporate or clinical environment required.
• Experience with the production or evaluation of radiographic images, particularly CT scans preferred
• Must be computer literate
• Linux experience is preferred.

Location:

Ft. Lauderdale, FL

Position Description:

The Senior Application System Engineer will develop the analysis, documentation and test of the integration of system components (software, robotic arm, implants, and surgical instruments) to deliver best-in-class robotic-assisted orthopedic solutions. The Senior Application System Engineer will work in close collaboration with the engineering, marketing, quality assurance and program management groups to deliver the product development roadmap and improve quality, clinical value, OR efficiency, and customer satisfaction for MAKO customers. Furthermore, the Senior Application System Engineer will support the continuous improvement of MAKO's product development tools and processes.

 Responsibilities:

• Designs/Involves in the “Design & Development” of system features with the software, Robotic Platform, implants, and surgical instruments of new and existing medical device/equipment products:
• Develops & writes specifications, flow- down specifications to sub-systems team(s),
• Develops & writes tests protocols,
• Develops & plans Systems Integration steps for the design & development of features of the RIO MAKO Application (software, Robotic Platform, implants, and surgical instruments)
• Analysis of the system feature:  purpose, scope, risks, targets, Gage R&R, DOE, statistical analysis, to support the flow-down of the systems, verification & validation.
• Be involved in the R&D strategy to develop new RIO MAKO Application
• Coach and mentor “Application System engineer” to learn “systems design” approach for RIO MAKO Applications with software, Robotic Platform, implants, and surgical instruments
• Responsible for the creation & execution of detailed project plans for systems design projects
• Conducts product testing and create models and prototypes.
• Troubleshoots the systems aspects of features implemented and proposed solutions.
• Executes assigned systems protocols, and writes the test results report. Participates in design review & verifications report review.
• Provide status updates on projects to Project Lead and/or Application System Director
• May be required to participate in R&D departmental policies and procedure updates.

Qualifications:

• Bachelor’s degree in an engineering discipline (or related science) with a minimum of 7 years technical experience in the design of medical systems. Master ‘s degree preferred in an engineering discipline (or related science) 
• Excellent Knowledge in “Systems Engineering” applied to medical devices.  
• Excellent Knowledge of Software Tools for statistical analysis.
• Knowledge of Matlab, Minitab, 3D CAD softwares (Solidworks)
• Excellent Knowledge of requirements, specifications systems process
• Excellent communication, reporting, and documentation skills
• Excellent  experience designing systems applied to medical equipment 
• Must be extremely detail oriented with strong written, verbal, interpersonal, computer, and organizational skills

Location:

Ft. Lauderdale, FL

Position Description:

The Senior Design Engineer designs and develops medical devices such as implants and implant related instruments from concept to product launch using his/her strong experience in design, manufacturing, quality inspection, materials, human factors and OR workflow.

Departmental Responsibilities:

Programs

• Design and develop new orthopedic implants and instrumentation and make improvements and modifications to current products.
• Participate in multiple simultaneous engineering projects consisting of design, prototype development, and testing through successful transition to manufacturing and product launch.
• Work independently on complex assignments from inception through timely, accurate completion and communicate with project leaders as necessary.
• Generate implant, instrumentation, Haptic, and visualization CAD models using SolidWorks.
• Generate detailed drawings and apply appropriate GD&T, material selection, surface finish, heat treatment, and notes. Efficiently review the drawings of others for completion and accuracy.
• Help define and execute specified requirements, risk analysis, verification, validation, and design transfer processes.
• Develop testing protocols according to external and internal standards and coordinate the activities required to fabricate test parts and complete mechanical testing at MAKO Surgical Corp. and/or outside testing laboratories.
• Interact with MAKO manufacturing personnel and product suppliers to facilitate and improve design for manufacturability and design for inspection.
• Share technical knowledge; provide leadership, mentoring and professional guidance to other team members.
• Interact with MAKO manufacturing personnel and product suppliers to facilitate and improve design for manufacturability and design for inspection.
• Provide technical support for marketing and sales such as design rationale, surgical technique, sales brochures, specification guides, product images, and computer animations.
• Prepare comparative analyses of competitive implant and instrument systems.
• Assist in building and maintaining an anatomic atlas through collection, segmentation, and organization of CT scans or other media.

General

• Uphold MAKO's Quality Policy
• Coordinate with the needs of the Research team to provide concepts, prototypes, or testing as needed.
• Build expertise in state of the art prototyping methods (SLA, DMLS, injection molding, materials, fidelity, suppliers/turn around time).
• Assist in preparing invention disclosures and patent applications; participate in patent reviews and patent analyses.
• Travel as necessary (estimated up to 20%) for project design meetings, support of sales and marketing activities, and professional meetings.

Qualifications/Requirements:

• Bachelor's degree in engineering with 5 plus years of experience in the field of medical device product design and development (hip, knee, spine, trauma, sports medicine preferred): combination of education and experience is acceptable
• Skilled expert in CAD modeling, drawings (SolidWorks preferred), and GD&T (per ASME Y14.5-2009)
• Skilled expert in mechanism and user-friendly instrument design
• Proficient understanding of OR workflow, OR layout, OR staff roles, and hospital central processing operation
• Self-driven, creative, and strong problem solving skills
• Superior written and spoken English communication, reporting, documentation, and organizational skills

Location:

Ft. Lauderdale, FL

Position Description:

Lead and participate in strategic quality planning. Partner with cross functional teams to continuously improve the Quality Management System (QMS). The appropriate candidate will complete quality deliverables throughout the phases of systems development per in FDA 21 CFR part 820 and ISO 13485 standards. Ensure all planning is risk-based specifically hazard and risk analysis. Will provide guidance to multiple project teams in order to ensure compliance to the company's quality systems and standards while enabling speed to market and attainment of company goals. Lead and conduct internal quality audits to ensure internal procedures are compliant to ISO standards and FDA regulations.

Responsibilities

• Develops Quality Plans for new quality systems that adhere to the QMS.
• Participate in quality plan reviews by identifying weaknesses and risks associated with the procedures and tracking the mitigation of those issues throughout the development process.
• Ensure that all required procedures in the QMS are compliant to ISO 14971.
• Partner with cross-functional departments as required in design, review, and verification that procedural requirements ensure appropriate objective evidence is available.
• Complete or contribute to the completion of final design verification and design validation test reports by providing clear concise conclusions with statistical validity and graphical support when necessary. 
• Utilize standard statistical analysis and problem solving techniques as necessary to determine product acceptance limits, establish process parameters, resolve quality problems, etc. 
• Work with Supplier Quality to identify supplier assessment requirements and communicate these to the supplier quality group. 
• Support quality system maintenance by identifying and correcting deficiencies in procedures and practices. 
• Lead and support CAPA teams in the analysis and resolution of product quality issues.
• Develop quality assurance documentation to support regulatory submissions. 
• Lead and implement QMS software solutions aimed at continuously improving the QMS.

Qualifications

• Bachelor's degree with a minimum of 5 years of experience in quality systems, new Product Development, auditing or combination of education and experience is required.
• Thorough knowledge of FDA QSR and / or ISO 13485 standards.
• Knowledge and understanding of ISO 14971 applications. 
• Ability to read and interpret CAD (e.g. Solidworks) drawings is required. 
• Strong technical, written, verbal, analytical, and interpersonal skills are essential.
• Self-motivated, strong time management, and organizational skills required.
• Strong statistical skills (e.g. ANOVA, distribution analysis, DOE, significance tests, process capability, sampling plans, regression, GR&R, etc.). 
• Certified ISO 13485 Lead Auditor preferred (ASQ or equivalent)
• Demonstrated experience using Microsoft Office products, Outlook and Minitab.
• American Society for Quality, Certified Quality Engineer (CQE) preferred.
• Training or certification in Six Sigma and Lean Methods is a plus.

Location:

Ft. Lauderdale, FL

Position Description:

The Temporary Senior Software Quality Assurance Engineer will provide quality assurance and testing support to the software development team throughout the software development lifecycle. The Senior Software Quality Assurance Engineer will lead the execution of the test plans to assure new or modified applications meet the company quality goals and expectations. This position will provide input into the quality processes with the goal of continually improving the effectiveness and efficiency of testing within the software QA team. Will ensure all quality assurance and testing activities are conducted throughout the software life cycle and that the results are documented. Work with minimal to no supervision on complex projects. Wide latitude for independent judgment. Assist less experienced peers. Highly-skilled with extensive proficiency.

Responsibilities:

• Analyze software requirements to ensure they are clear and testable.
• Participate in software design reviews
• Executes test plans to verify adherence to the company's development process and software requirement specifications.
• Create, review and execute test cases to verify the correct functionality, usability, performance and reliability of systems and applications.
• Creates clearly documented bug reports for anomalies found during test procedures.
• Document and communicate testing activities and results.
• Document and track defects (bugs) utilizing designated tools. Verify bug fixes and document results.
• Assist in test planning activities.
• Assist in writing testing procedure documentation.
• Works closely with development and support groups to facilitate software releases.
• Support quality system maintenance as it relates to software.
• Will mentor and/or provide training to less experienced peers.

Qualifications Required:

• Bachelor's degree in Computer Science, Information Technology or related field with a minimum of (8) years software testing experience; combination of experience and education is acceptable.
• Advanced working knowledge of Linux/Unix.
• Experience in a regulated software development environment desirable.
• Prior experience with C or C++ and Tcl/Tk required
• Demonstrated experience using Windows, Microsoft Office, and Outlook.
• Strong aptitude and interest in software testing
• Demonstrated experience in the following: software testing methods, test plan and test case development, software risk analysis and software development practices.
• May require attendance in cadaver labs or O.R. setting

Location:

Ft. Lauderdale, FL

Position Description:

The engineer's primary responsibility is to design, develop and maintain application software for robot assisted surgery products. The engineer works closely with peers in software engineering and project and product management. In developing software that meets the specified requirements. Following defined design practices and the use of sound software engineering principles, the engineer ensures that the application software products are safe, robust and user friendly. Work under general supervision with latitude for independent judgment. May consult with senior peers on certain projects.

Responsibilities:

• Work as part of a team using established company practices for Agile Software Development.
• Maintain existing code and develop new code in Tcl/Tk for surgical applications.
• Follow company standards for code documentation
• Participate in software planning and estimating activities.
• Work with other departments in identifying root causes of problems and potential solutions.
• Ensure the integrity and security of company intellectual property and confidential data.
• Comply with ongoing training requirements.
• Attend and support cadaver labs.

Qualifications:

• Bachelor's degree in computer science or related field.
• Graduate degree or at least two years of industry experience with professional software development.
• Proficiency in 3D geometry and computer graphics.
• Strong communication skills required.
• Proficiency with Tcl/Tk or other scripting language highly desired.
• Linux or Unix-based software development skills highly desired.
• Experience with C language development a plus.

Location:

Ft. Lauderdale, FL

Position Description:

The Software Quality Assurance Engineer will provide quality assurance and testing support to the software development team throughout the software development lifecycle. The Software Quality Assurance Engineer will lead the execution of the test plans to assure new or modified applications meet the company quality goals and expectations. This position will provide input into the quality processes with the goal of continually improving the effectiveness and efficiency of testing within the software QA team. Will ensure all quality assurance and testing activities are conducted throughout the software life cycle and that the results are documented. Work with minimal to no supervision on complex projects. Wide latitude for independent judgment. Assist less experienced peers. Highly-skilled with extensive proficiency.

Responsibilities:

• Analyze software requirements to ensure they are clear and testable.
• Participate in software design reviews
• Executes test plans to verify adherence to the company's development process and software requirement specifications.
• Create, review and execute test cases to verify the correct functionality, usability, performance and reliability of systems and applications.
• Creates clearly documented bug reports for anomalies found during test procedures.
• Document and communicate testing activities and results.
• Document and track defects (bugs) utilizing designated tools. Verify bug fixes and document results.
• Assist in test planning activities.
• Assist in writing testing procedure documentation.
• Works closely with development and support groups to facilitate software releases.
• Support quality system maintenance as it relates to software.
• Will mentor and/or provide training to less experienced peers.

Qualifications Required:

• Bachelor's degree in Computer Science, Information Technology or related field with a minimum of (5) years software testing experience; combination of experience and education is acceptable.
• Advanced working knowledge of Linux/Unix.
• Experience in a regulated software development environment desirable.
• Prior experience with C or C++ and Tcl/Tk required
• Demonstrated experience using Windows, Microsoft Office, and Outlook.
• Strong aptitude and interest in software testing
• Demonstrated experience in the following: software testing methods, test plan and test case development, software risk analysis and software development practices.
• May require attendance in cadaver labs or O.R. setting

Location:

Ft. Lauderdale, FL

Position Description:

The Software Valdiation Engineer is responsible for performing software validation for the "off the shelf" software packages, and ensuring software is designed and built in accordance with company and customer quality requirements.

Responsibilities:

• Working with stakeholders (e.g., System Administrator, IT personnel, system/process owners) on requirements definition in order to define test scenarios and strategies. 
• Identifying potential risks in the planning, development, implementation, and maintenance of a software application and assisting in creation of mitigation strategies and contingency procedures 
• Proactively supporting software development in a Quality Assurance capacity 
• Engineering positive and negative test data to develop test cases that validate that the software satisfies all requirements 
• Analyzing and writing requirements, test protocols and test reports for Off the Shelf software package 
• Writing technical documentation, procedures and policies 
• Recording, tracking, and assisting in the resolution of software defects/issues 
• Designing software validation plan, test plan, traceability, and validation report documents 
• Assuring appropriate test coverage in accordance with operating procedures and regulatory requirements 
• Ensuring the accuracy, completeness and compliance of documents deliverables 
• Providing technical support and guidance to personnel utilizing validated software 
• Participating in Change Control process, revising Test specifications and test protocols to implement changes to determine adequacy and correctness and validating changes to ensure that changes are correctly incorporated in the software products. 

Qualifications/Requirements:

• Minimum of Bachelor degree in Computer Science, Engineering or related field 
• Minimum of 4 years of experience in developing test specifications, test protocols and executing protocols for software test and validation at unit, module and system level. 
• Knowledge of Requirement, Test Protocol, Defect and risk Management tools is a plus 
• Technical foundation with a strong understanding of the Software Development Life Cycle and Software Quality Assurance methodologies 
• Proficiency in technical writing with strong attention to detail 
• Knowledge of relational database concepts and SQL preferred 
• Experience with Microsoft Office Suite to include writing documents and analyzing data using Excel Familiarity with current medical device industry standards and guidelines such as cGMP, FDA (21CFR, 21CFR Part 11), and ISO is a plus 
• Excellent communication, analytical, and interpersonal skills 

Location:

Ft. Lauderdale, FL

Position Description:

This position will be responsible for supporting senior team members in carrying out the responsibilities of the Finance/Accounting Department, which includes, but not limited to, monthly financial closes, reporting to internal customers, and providing ad hoc analysis upon request. The position will report directly to the Assistant Controller. In addition, this person must be able to work independently and efficiently to meet deadlines with minimal supervision.

Departmental Responsibilities

• Maintain the fixed asset and associated depreciation schedules
• Prepare monthly commission calculations in accordance with the variable compensation plans
• Prepare journal entries
• Prepare and analyze account reconciliations
• Assist in month-end close
• Work on special projects, as needed
• Other accounting functions as assigned by the Controller

Qualifications

• Bachelor's degree in accounting
• Minimum of 1 year of accounting experience
• Strong financial and analytical skills
• Basic PC skills; Intermediate MS Word; Advanced MS Excel skills required

Location:

Phoenix, AZ

Position Description:

Provides clinical sales support to all end users and provides on-site guidance and assistance during surgical procedures. Leads continuous account growth of the clinical base by working with key hospital staff, thought leaders and referring doctors in territory to develop a referral base and increase procedural/implant volume. Drives case volume and site growth by translating clinical benefits of MAKOplasty into the economic benefits.Obtains purchase orders for products consumed during surgical procedures and maintains and tracks consigned inventories of company's products. Provides training, ongoing in-services, and customer education to assigned account(s).  Provides feedback on product design to improve performance and customer satisfaction.  Partners with Account Executives and other cross functional teams in selling the clinical benefits of the company’s products. Manages and develops MAKOplastySales Specialists team members within multiple locations.

Leadership Responsibilities

• Mentoring and developing the clinical, sales and marketing skills of new hires in the field
• Acts as lead in account launches, partnering with the District Sales Manager and the Field Service Organization to ensure the highest level of customer satisfaction and launch success
• Partners with MAKOplasty Sales Specialist as the “clinical expert” during initial cases to ensure optimal OR flow and quality program adherence
• Actively participates in the interviewing process of new hires for the MAKOplasty Sales Specialist role
• Takes a lead at Roadshows and Sales Demonstrations, to provide potential customers with opportunity to test product and apply their experience towards the clinical value of consistently reproducible precision
• Is actively engaged with system validations as directed by management
• Works with the District Manager in developing a sales plan tailored to targeted market, including multiple locations
• Produces sales orders and provides case, material and revenue forecast input to MAKO

Key Responsibilities

• Provides surgeons and operating room staff with training and support in the operation of the company's robotic arm applications, associated equipment and instruments to insure ideal placement and precision
• Provides complete reports and associated metrics to management, direct supervisor and company's regulatory department detailing case reviews, services performed and recommendations for product, documentation and methodology improvements
• Maintains and controls local MAKO consigned equipment, instrument, implant and disposables inventories
• In conjunction with other teams, trains physicians and hospital personnel, including Operating Room staff, radiology and central sterile processing on the use of the RIO System, accessories, disposables and implants
• Provides daily communications with customers to ensure resolution and proper follow-up on FDA complaints and / or service reports, leading to higher customer satisfaction and clinical value
• Supports clinical affairs manager on MAKO clinical studies to ensure they are executed appropriately and that all data is collected and communicated in a timely manner while respecting all aspects of HIPAA regulations; also supports product evaluation surveys and KCE (Knee Center of Excellence) agreements.
• Work with senior hospital staff, customer marketing and key surgeons in the development and execution of a plan to effectively increase implant/procedural volume at customer sites.
• Provide case coverage at other accounts as needed.

Other Responsibilities

• Develop marketing plans, account plans, ROI analytics and proposals for new robotic arm applications and implants in direct collaboration with new product introduction strategies
• Drive continuous expansion of the user base across multiple accounts by working with key hospital staff, thought leaders, MAKO, and referring doctors in territory to develop a solid call list in CRM.
• Collaborate with marketing to increase public awareness of the benefits of consistently reproducible results and robotic arm orthopedics
• Effectively collect, create, and qualify high potential leads to convert to sales opportunities
• Responsibly manage administrative tasks as assigned. Main administrative tasks include: reporting of sales/procedures, outcomes of sales activities, submission of expense reports, logging all sales activity in CRM, forecasting, timely submissions and prospecting activities.

Requirements

• BS/BA Degree with a minimum of 6 years experience; combination of experience and education is acceptable.
• Has mastered cadaver lab training for surgeons and validation purposes
• Proven track record in sales, preferably with a surgical device company (Orthopedics preferred)
• Ability to read and teach the Segmentation of  CT Scans and reading of rendered images
• Excellent interpersonal and communication skills
• Knowledge of the Operating Room environment/orthopedics preferred
• Ability to operate a PC and use Windows based software
• Ability to work in a team oriented environment
• Self-motivated / directed, detail oriented and a proven history of ability to make independent decisions in a fast-paced, dynamic business environment
• Ability to travel up to 75%
• Must maintain current credentials as required by MAKO Surgical Corp. and clinical sites (i.e. EHS training, vaccination requirements, HIPAA certifications, etc.)
• Must have valid driver’s license.