Engineer III
Branchburg, New Jersey, United States
Job Description
- Location: Branchburg, NJ (Hybrid)
- Serve on project technical team, consisting of cross-functional resources including but not limited to R&D, PDS&T, Quality, Biocompatibility, and Regulatory.
- Partner with R&D to identify user and technical product requirements for a medical device product.
- With Technical Lead, develop Design Verification & Validation strategy.
- Support Design Verification (planning, fixture development, method development, test method validation, protocol development, and test execution).
- Drive the creation and execution of protocols and reports.
- Manage Design History File content.
- Participate in prototyping activities to transform concepts into functional devices.
- Perform laboratory testing, including independently designed experiments to further project goals.
- Conduct statistical analyses using software such as Minitab or JMP to evaluate data and support design decisions.
- Ensure compliance with company and industry standards regarding safety, quality, and regulatory policies (including GxP).
- Bachelor's Degree or equivalent education with 5 or more years of experience or Master's degree or equivalent education with 3 or more years of experience.
- Experience with new product development, including defining user and technical product requirements.
- Experience with Design controls, including Design Verification & Validation strategy development and execution.
- Experience with laboratory testing as well as subsequent data analysis using statistical methods.
- Experience with medical device regulatory submissions.
- Experience with biological-based products preferred.
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