The Product Development Engineer I supports product development activities from concept through commercialization, executing design controls, testing, risk management, and documentation in compliance with QMSR, ISO 13485:2016, and ISO 14971.
Duties and Responsibilities:
Support design transfer activities including DFM/DFA input, pilot builds, process development, and required documentation.
Develop and validate test methods; design simple fixtures to enable repeatable testing.
Maintain requirements traceability and contribute to formal design reviews.
Execute verification protocols, analyze data, and generate compliant reports.
Perform feasibility studies, product characterization, and risk analysis.
Collaborate cross-functionally with Quality, Regulatory, Manufacturing, and suppliers.
Participate in customer meetings and present technical updates as needed.
Maintain accurate engineering documentation throughout all development phases.
Numbers & Facts
Location
Maple Grove, Minnesota
Skills
Cross-Functionalunmatched
Data Analysisunmatched
Documentationunmatched
Feasibility Analysisunmatched
ISO (International Organization for Standardization)unmatched
Maintain Complianceunmatched
Manufacturing Requirementsunmatched
Process Developmentunmatched
Product Developmentunmatched
Product Engineeringunmatched
Product Supportunmatched
Protocol Analysisunmatched
Quality Assurance Methodologyunmatched
Reporting Skillsunmatched
Risk Analysisunmatched
Risk Managementunmatched
Technical Presentationunmatched
Test Designunmatched
Test Plan/Scheduleunmatched
Testingunmatched
Traceabilityunmatched
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