Product Development Engineer
About The Position
The Product Development Engineer is engaged in executing the main elements of New Product Development to introduce surgical implants, prosthetics, and instruments to market. In this role, you will participate in the following: Concept Development, Design & Development, Design Verification & Validation, and Design Transfer to production. You will serve as a core team member of the Design Engineering team, while partnering with cross-functional experts on projects. You will participate in the planning and execution of Design Verification & Validation activities and participate in activities including product & packaging performance evaluation, Biocompatibility assessments, Usability Studies and Sterilization Validation assessment.
Requirements
- Bachelor’s degree in Mechanical Engineering or Biomedical Engineering
- Minimum 2 years’ experience in product development; medical device or another highly regulated industry is highly preferred
- Proficient in 3D CAD modeling and Engineering Drawings (SolidWorks or similar).
- Strong technical writing skills and experience writing product requirements, specifications, test protocols and test reports, and engineering rationales.
Responsibilities
- Generate product development documentation ensuring compliance with internal operating procedures, ISO 13485 and FDA 21CFR Part 820.30.
- Conduct risk management activities (FMEA) and document results ensuring compliance with internal procedures and ISO-14971.
- Conduct biocompatibility and sterilization evaluations and generate documentation ensuring compliance with internal procedures, ISO 10993-1 and ISO 11737.
- Perform Finite Element Analysis if needed.
- Perform statistical analysis for test results and sample size rationalization.
- Review dimensions of parts, materials to be used, relations of one part to another, and relation of various parts to whole structure of product lines.
- Review and approve drawings, applying knowledge and experience utilizing Geometric Dimensioning & Tolerancing (GD&T) per ASME Y14.5
- Develop engineering protocols/reports, initiates Change Orders (CO) and prepare engineering documentation.
- Assist in project activities to coordinate new product introductions.
- Coordinate with vendors and other project participants to ensure timely response to action items.
Benefits
- medical/dental/vision benefits
- 401K match
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
