Bachelor's Degree in Engineering or a related scientific field; Electrical Engineering preferred
3-5 years of Class II electro-mechanical medical device experience
Experience with Design Controls and Risk Management
Experience with medical device compliance testing, including EMC, EMI, and IEC testing
Experience working with external testing organizations such as TÜV and Intertek
Experience with technical design documentation, V&V protocols, and

DFMEA/PFMEA

Strong Microsoft Word and Excel skills Desired Skills & Experience
Knowledge of FDA QSRs, ISO 13485, ISO 14971, and IEC standards
Experience with Design/Process Validation and Verification, including

IQ/OQ/PQ

FDA, CE, or other regulatory submission experience
Knowledge of statistical analysis and Minitab
Experience with lasers and optical technologies What You Will Be Doing
Support Design Controls, Risk Management, and FMEA activities
Plan and execute Verification & Validation activities
Support regulatory and compliance testing
Maintain technical documentation and design records
Analyze test data and support engineering decisions
Collaborate with Design Engineering, Regulatory, Quality, and external testing teams Tech Breakdown
30% Design Controls & Risk Management
25% Verification & Validation
20% Regulatory & Compliance
15% Technical Documentation
10% Statistical Analysis & Testing Daily Responsibilities
40% Hands-On Engineering & Design Assurance
25% Risk Analysis & Design Documentation
20% Regulatory & Compliance Support
15% Cross-Functional Team Collaboration The Offer
Medical, Dental, and Vision Insurance with HSA/FSA options
401(k) Plan with Company Matching Applicants must be currently authorized to work in the US on a full-time basis now and in the future.

Motion Recruitment Partners (MRP) is an Equal Opportunity Employer. All applicants must be currently authorized to work on a full-time basis in the country for which they are applying, and no sponsorship is currently available. Employment is subject to the successful completion of a pre-employment screening. Accommodation will be provided in all parts of the hiring process as required under MRP's Employment Accommodation policy. Applicants need to make their needs known in advance. Active Filters Design Assurance Engineer / Clas... 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Design Assurance Engineer / Class II Medical Devices