IPG Photonics is revolutionizing the laser industry as the pioneering developer and leading producer of fiber lasers and amplifiers. Headquartered in Marlborough, MA, IPG has over 4,800 employees in more than 30 locations around the world. We aspire to work together with our employees and customers to apply light in ways that improve life.
Our mission is to develop innovative laser solutions to make the world a better place. To accomplish this mission, we are committed to attracting and retaining the best talent and an engaged and thriving workforce that drives a sustainable future for our company and society.
Working at IPG Photonics you can expect challenging projects, a motivating and friendly environment, and competitive benefits.
Position Summary
The Verification and Validation Test Engineer designs, builds, and validates test methods for verification and validation testing for medical devices and disposables in an ISO 13485 and FDA QSR compliant environment. This Role reports to Quality Management, supporting various project teams in different stages of project maturity from R&D through Production.
Key Responsibilities
- Medical Device Testing: Execute Design Verification and Validation activities for complex electromechanical devices and single-use disposables.
- Test Method Development: Design, develop, validate and execute test methods to inform design decisions and verify system functionality.
- Documentation: Author test protocols, data sheets, and final reports. Author/assist manufacturing procedures, machine instructions.
- Quality Compliance: Ensure all activities align with ISO 13485, FDA 21 CFR Part 820, and risk management standards.
- Data Analysis: Apply statistical techniques like ANOVA, Gage R&R, and capability analysis to test datasets.
- Communication: Present test findings to relevant stakeholders, communicate risk and countermeasure insights as applicable.
Required Qualifications
- Education: Bachelor's degree in Mechanical, Electrical, Biomedical, or Quality Engineering
- Experience: 1-3 years of engineering experience within the medical device or regulated industry.
- Regulations: Working knowledge of ISO 13485, FDA QSR, and ISO 14971 risk management standards.
- Verification & Validation: Direct experience in planning and/or execution of Verification and Validation for complex electrotechnical devices.
- Technical Tools: Proficiency with data acquisition systems, and proficiency in analysis tools such as Excel and Python, or statistical software like Minitab.
- Lab Skills: Hands-on experience using mechanical test equipment like tensile testers, gauges, and sensors.
Preferred Qualifications
- Experience with endoscopic surgical laser systems
- Experience supporting Design Verification activities for complex medical systems.
- Experience working with mixed hardware and software systems.
- Experience preparing technical documentation for regulatory submissions.
- Experience using Minitab, Linux, and Python.
MA: $74,956 - $87,136 MA: $74,956 - $87,136
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
- Paid sick time
- 12 (twelve) Paid Holidays Each Calendar Year
- 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
- Parental Bonding Leave
- Bright Horizons Backup Care
- Bright Horizons College Coach
- Benefits eligibility may differ by program for reduced hour schedules Deadline and How to Apply This job posting will remain active until a candidate is identified and/or the Company rescinds the job posting. For full consideration, please click on the link to apply.