Summary:

The Senior Product Development Engineer is responsible for complete development activities of medical devices, including concept generation, design, development, testing, and product maintenance. This position will work closely with key surgeons to bring products from idea / concept through to commercialization. The Senior Product Development Engineer will lead and participate on cross-functional project teams through all phases of the product development process. 

 

 

Position Responsibilities:

•      Design and development of implant and instrument systems for surgical use.

•      Reviews, initiates or approves engineering drawings, layouts, change orders and specifications.

•      Exhibit strong written and verbal communication skills and interface effectively with surgeons.

•      Plans, schedules, conducts, or coordinates detailed phases of the engineering work in a part of a major project.

•      Reviews test protocols, procedures and test reports.

•      Reviews and maintains all necessary paperwork and documentation for the DHF in accordance with all Regulatory guidelines.   

•      Works closely with other departments to coordinate design engineering activities.

•      Determines budgets and timelines for assigned projects.

•      Supports Marketing, Surgeons, and Sales teams with technical information to be used for training and marketing of assigned products.

•      Supports manufacturing teams to provide processing improvements.

•      Some travel may be required (up to 10%).

 

Qualifications:

•      At least 5 years of engineering experience in the commercialization of orthopedic devices.

•      BS or MS Degree in Engineering required.

•      Proficiency in Solidworks.

•      Knowledgeable of FDA and ISO guidelines for the development of medical devices required.

•      DFM knowledge and experience including manufacturing methods.

•      Strong technical communication skills and proven track record to work independently with external suppliers

•      Working knowledge of orthopedic anatomy.

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