Design Assurance Engineer - Marlborough, MA

IPG Photonics Corporation

Marlborough, MA, United States

about 1 month ago

Apply on diversityjobs.com

Prepare application

Role details

Contract type

Permanent contract

Employment type

Full-time (> 32 hours)

Experience level

Experienced

Experience required

3 years minimum

Working hours

Regular working hours

Job source

diversityjobs.com

Tech stack

Microsoft Word Microsoft Excel Analysis of Variance (ANOVA) Software Design Documents Failure Mode Effects Analysis Statistical Hypothesis Testing Minitab Verification and Validation (Software) Iq/oq/pq

Job description

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 IPG products
Assist regulatory department with FDA, CE, and other regulatory submissions
Perform all other essential duties as assigned

Requirements

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
Experience with lasers and optical technologies desired, but not necessary
Strong working knowledge of Microsoft Word and Excel