Medical Devices Design Assurance Engineer

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 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 TUV 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

You will receive the following benefits:

· 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.