Design Assurance Engineer

Marlborough, Massachusetts, United States

Working at IPG Photonics you can expect challenging projects, a motivating and friendly environment, and competitive benefits.

• 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

• 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

225 Cedar Hill Street, Marlborough , Massachusetts 01752 , United States

Exempt

MA: $74,956 - $99,316

Pay Range
:

The pay range on this posting applies to the role in the primary location specified. If the candidate would ultimately work outside of the primary location posted, the applicable range could differ. Actual starting pay is determined by a number of factors including relevant skills, qualifications, and experience.

Other Compensation
:
Employees in this role are eligible for additional rewards which could include:

• Annual Discretionary Bonus or Sales Bonus as Applicable

Benefits Provided
:
All Regular
* US employees receive:

• Paid vacation time accrued based on years of service

* Prorated for reduced hour schedules

Additional Benefits Offered
: IPG also offers access to:

• Medical, dental, and vision insurance plans with options for HSA/FSA
• Dependent Care FSA
• Paid Basic Life and AD&D Insurance
• Short-term and Long-term Disability insurance
• 401(k) plan with Company matching
• Employee Stock Purchase Plan (ESPP)
• Tuition Reimbursement Program
• Employee Assistance Program (EAP)
• Adoption Assistance
• Pet Insurance
• Bright Horizons Backup Care
• Bright Horizons College Coach

* Benefits eligibility may differ by program for reduced hour schedules

EEO is the Law