Senior Development Engineer, Implants

Locations:
Ft. Lauderdale, FL

Applicants: Click here to apply
 


Position Description:

The Senior Development Engineer manages the design and development of implant and implant related instruments and projects from concept to product launch using his/her strong experience in human body biomechanics, medical device industry requirements, project management, and design controls.

Departmental Responsibilities:

• Lead the design and development of new orthopedic implants and instrumentation and improvements and modifications to current products.
• Oversee and participate in several simultaneous engineering projects consisting of design, prototype development and testing through successful transition to manufacturing and product launch.
• Generate project schedules, set individual milestones, work independently on complex assignments from inception through timely, accurate completion and communicate with project leaders as necessary.
• Define and execute specified requirements definition, risk analysis, verification, validation, and design transfer processes for all products under direct responsibility.
• Maintain design history files to ensure compliance with FDA and international regulatory agencies design control regulations and to support the Regulatory team with necessary submissions and files.
• Share technical knowledge; provide leadership, mentoring and professional guidance to junior engineers.
• Provide technical support for marketing and sales such as design rationale, surgical technique, sales brochures, specification guides, computer animations, and prepare internal and external training presentations.
• Generate implant and instrumentation CAD models and detailed drawings using SolidWorks software.
• Develop mechanical test 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 manufacturability.
• Interact with Product Management/Marketing/Sales and Quality (where appropriate) to obtain feedback on new product designs and necessary changes to existing designs.
 

• Uphold MAKO’s Quality Policy
• Assist in preparing invention disclosures and patent applications; participate in patent reviews and patent analyses.
• Coordinate with the needs of the Phase 0 team to provide them with prototype design, concepts or testing as needed.
• Communicate with surgeons and sales consultants, 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.

• Bachelor’s Degree in Mechanical or Biomedical Engineering
• 5+ years of experience in the field of medical device product design and development
• Project management experience including leading a project from concept to production
• Self-driven, creative, and strong problems solving skills
• A high level of CAD, Microsoft Office, and Microsoft Project proficiency is required
• Superior written and spoken English communication, reporting, documentation, and organizational skills