Design Assurance Engineer ​/ Class II Medical Devices

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.

• 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

• 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

• 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

• 30% Design Controls & Risk Management
• 25% Verification & Validation
• 20% Regulatory & Compliance
• 15% Technical Documentation
• 10% Statistical Analysis & Testing

• 40% Hands-On Engineering & Design Assurance
• 25% Risk Analysis & Design Documentation
• 20% Regulatory & Compliance Support
• 15% Cross-Functional Team Collaboration

• 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.