Product Development Engineer II

2 weeks ago

Parsippany, United States Extremity Medical Full time
Job DescriptionJob Description

Overview: Design, develop, verify, and validate Class I and II medical implants and instruments through the product lifecycle, specifically for use in foot/ankle, hand/wrist indications. Collaborate in a multidiscipline team of Engineers, Surgeons, Sales, Marketing, QA/RA, and Operations to innovate and launch novel products. Perform all functions through the development cycle, from concept to commercial launch.

Responsibilities:

  • Design and develop new implants and instruments for upper and lower extremity.
  • Interact with surgeons, manufacturing, regulatory affairs, marketing, and other functional departments to define and develop product requirements and concepts.
  • Works side by side with surgeon teams for design concept development, prototype, verification, and validation.
  • Generates 3D models, concept layouts, and engineering drawings using SolidWorks CAD software.
  • Leads product development cadaver labs to support design verification and validation.
  • Develops and implements mechanical test protocols according to ASTM and ISO standards.
  • Modifies existing designs to facilitate manufacturability and scalability.
  • Collaborates with Marketing and Product Management to provide technical information to be used for marketing and medical education training collateral materials.
  • Management of design controls from concept development through product launch.
  • Adhere to ISO 13485 Design Controls and support 510(k) or technical file submissions.

Qualifications:

  • At least four years’ experience in the design and development of mechanical products with a successful track record of product launches and project management.
  • Experience in orthopedic medical device industry a must, with preference to have experience in internal fixation, external fixation, trauma, nails, nitinol, and/or sports medicine disciplines.
  • Knowledge of CAD software (SolidWorks preferred), as well as familiarity with Finite Element Analysis.
  • Knowledge of good engineering practices, drafting and GD&T standards
  • Strong communication and interaction skills, with the ability to interface with surgeons and sales/marketing personnel.
  • Self-starter and team player who has the initiative, ability, and personal drive to interface with people inside and outside of the company exhibiting the highest level of professionalism.
  • Hands-on engineer.
  • BS or MS in Biomedical or Mechanical Engineering, MS preferred

SALARY: Commensurate with experience

Company DescriptionExtremity Medical is an orthopedic implant and instrument company focused on fusion and motion preservation in the foot and ankle, and hand and wrist. The company sells approximately 15 product lines both in the US and internationally. The company is focused on development of novel products to meet customer needs.Company DescriptionExtremity Medical is an orthopedic implant and instrument company focused on fusion and motion preservation in the foot and ankle, and hand and wrist. The company sells approximately 15 product lines both in the US and internationally. The company is focused on development of novel products to meet customer needs.

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