Design Assurance Engineer
Job in
Marlborough, Middlesex County, Massachusetts, 01752, USA
Listed on 2026-09-13
Listing for:
The Judge Group
Full Time
position Listed on 2026-09-13
Job specializations:
-
Engineering
Quality Engineering, Regulatory Compliance Specialist, Biomedical Engineer
Job Description & How to Apply Below
- Conduct product design control activities for new and sustaining product development efforts
- Support risk analysis activities, including design and process FMEA
- Support Process/Design Validation/Verification activities, including software validation and IQ/OQ/PQ activities
- Support Design Engineering in the creation of Design History and Technical Files
- Interact with third-party test houses that conduct compliance testing of company products
- Assist regulatory department with FDA, CE, and other regulatory submissions
- Perform all other essential duties as assigned
Education and Experience
- Bachelor's Degree in scientific or engineering field; electrical engineering is preferred
- 3-5 years of experience with engineering and development of Class II electro-mechanical medical devices
- Knowledge of Design Controls and Risk Management practices, regulations and standards, such as FDA QSR's, ISO 13485, ISO 14971, IEC 60601, 60825, 62366, and 62304 is preferred
- Supporting medical device compliance testing (e.g. EMC, EMI, IEC) with external test houses, such as TUV an Intertek
- Maintenance of technical design documentation, such as design specifications, verification/validation protocols, and DFMEA/PFMEA.
- Working knowledge of advanced statistical methods (e.g., hypothesis testing, DOE, ANOVA, R&R studies, capability, tolerance interval analysis, power and sample size determinations, etc.), including statistical software tools, such as Minitab, is preferred
- Strong working knowledge of Microsoft Word and Excel
To View & Apply for jobs on this site that accept applications from your location or country, tap the button below to make a Search.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).
Search for further Jobs Here:
×