Design Assurance Engineer / Class II Medical Devices

We are seeking a Design Assurance Engineer to join our team in Marlborough, MA, supporting the development and sustaining of advanced Class II electro-mechanical medical devices.

About the role

This full-time position focuses on design controls, risk management, verification and validation, regulatory compliance, and technical documentation. 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.

Responsibilities

• 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

Requirements

• 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

Preferred Qualifications

• 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

Benefits

• 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.