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., 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 TV 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

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