A leading global technology company is looking for a Design Assurance Engineer to join their team in Marlborough, MA. This is a full-time opportunity supporting the development and sustaining of advanced Class II electro-mechanical medical devices, with a focus on design controls, risk management, verification and validation, regulatory compliance, and technical documentation.
This is a great opportunity for a Design Assurance Engineer with 3-5 years of Class II electro-mechanical medical device experience who wants to have a direct impact on the quality and compliance of innovative products. You’ll work across the full product development lifecycle, from FMEA and design controls through compliance testing and FDA/CE submissions. Experience with lasers and optical technologies is a plus.
Required Skills & Experience
- 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 TUV 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.
