Medical Devices Design Assurance Engineer

About the role

We are seeking a Design Assurance Engineer to join our team in Marlborough, MA. This full-time opportunity supports the development and sustaining of advanced medical device products, with a focus on design controls, risk management, verification and validation, regulatory compliance, and electro-mechanical medical device technologies. You’ll work closely with Design Engineering, Regulatory teams, and external testing organizations to help bring safe, compliant products from development through market release.

This role is ideal for someone with 3–5 years of Class II electro-mechanical medical device experience who wants to directly impact the quality and compliance of innovative products. You’ll gain exposure across the entire product development lifecycle—from FMEA and design controls to compliance testing and FDA/CE submissions—while partnering with engineering and regulatory teams. Experience with lasers and optical technologies is a plus.

Responsibilities

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

Daily responsibilities include:

• 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 a scientific or engineering field; Electrical Engineering preferred
• 3–5 years of experience with engineering and development of Class II electro-mechanical medical devices
• Experience with Design Controls and Risk Management practices
• Experience supporting medical device compliance testing, including EMC, EMI, and IEC testing
• Experience working with external testing organizations such as TÜV and Intertek
• Experience maintaining technical design documentation, including design specifications, verification/validation protocols, and DFMEA/PFMEA
• Strong working knowledge of Microsoft Word and Excel

Qualifications

• Knowledge of FDA QSRs, ISO 13485, ISO 14971, IEC 60601, IEC 60825, IEC 62366, and IEC 62304
• Experience with Process/Design Validation and Verification activities, including software validation and IQ/OQ/PQ
• Experience supporting FDA, CE, and other regulatory submissions
• Knowledge of advanced statistical methods, including hypothesis testing, DOE, ANOVA, R&R studies, capability, tolerance interval analysis, and power/sample size determinations
• Experience with statistical software such as Minitab
• Experience with lasers and optical technologies

Benefits

• Paid vacation time accrued based on years of service
• Paid sick time
• 12 paid holidays each calendar year
• Medical, Dental, and Vision Insurance with HSA/FSA options
• 401(k) Plan with Company Matching
• Employee Stock Purchase Plan (ESPP)
• Tuition Reimbursement Program

Applicants must be currently authorized to work in the US on a full-time basis now and in the future.