Medical Devices Design Assurance Engineer Job Marlborough area,Massachusetts USA,Engineering

Medical Devices Design Assurance Engineer

This is a full-time opportunity supporting 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 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 get 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, making this an especially interesting role for someone looking to expand their experience in advanced medical device technology.

Required Skills & Experience

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

Desired Skills & Experience

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

What You Will Be Doing

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

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