Product Development Engineer
Skills
- Experience with medical device development and design control documentation
- Verification & validation test planning and execution
- SolidWorks proficiency for 3D CAD modeling and drawings
- Experience with manufacturing transfer and production support
- Supplier qualification and component/assembly management
- Risk assessment and DFMEA/PFMEA experience
- Familiarity with IQ/OQ/PQ and other validation protocols
- Strong communication, collaboration, and problem-solving skills
Responsibilities
- Lead product and feature development from concept through manufacturing transfer in coordination with marketing, program management, operations, and quality.
- Generate prototypes and own verification and validation testing, including authoring test protocols and reports (design verification and validation).
- Manage relationships with component and assembly suppliers to qualify parts, tools, and assemblies.
- Develop manufacturing procedures, processes, tooling, and fixtures to meet production and quality requirements.
- Provide production line support, implement process improvements, troubleshoot equipment, and address product issues with operations and quality.
- Write and execute process and equipment validations (IQ/OQ/PQ/MVP/TMV) and perform associated risk management activities (DFMEA/PFMEA/Risk Assessment).
- Create and maintain 3D CAD files and component prints; lead ongoing product and process improvements based on user feedback.
Education
- Bachelor's degree in engineering (required)
- Advanced engineering degree preferred
Benefits
- Competitive medical, dental, and vision insurance
- 401(k) retirement plan with employer match
- Paid time off and holidays
- Professional development and training opportunities
- Flexible/hybrid work arrangement and commuter-friendly location
Average salary estimate
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