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 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
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.
