The Role
Design, build, and validate test methods for electromechanical devices and single-use disposables. Plan and execute verification and validation activities, develop and validate test methods and fixtures, author protocols and reports, ensure ISO 13485/FDA QSR/ISO 14971 compliance, perform statistical data analysis (ANOVA, Gage R&R), and present findings to stakeholders.
Summary Generated by Built In
Job Summary & Responsibilities
Position Summary
The 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
- Verification Testing: Plan and execute Design Verification and Validation activities for com plex electromechanical devices and single-use disposables
- Test Method Development: Design, develop, validate and execute test methods to inform design decisions and verify system functionality
- Research & Development: Conduct early-stage exploratory testing and characterization to support design inputs
- Equipment Development: Design, fabricate, and assemble custom test fixtures and automated equipment
- Equipment Validation: Write and execute protocols and reports for test software and hardware
- 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, or 3-4 additional years of trade experience
- Experience: 2–5 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 execution of Verification and Validation for complex electrotechnical devices
- Validation Skills: Direct experience writing and executing Equipment IQ/OQ/PQ and Test Method Validation (TMV)
- Technical Tools: Proficiency with data acquisition systems, and proficiency in analysis tools like MATLAB, 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 with surgical fluid irrigation/aspiration systems and components (pumps, pressure sensors, flow sensors)
- Experience testing polymer-based fluid delivery components or single-use medical disposables (biocompatibility, sterilization validation)
- SolidWorks or CAD proficiency for mechanical fixture design
- Experience coding data acquisition using Python / C, able to troubleshoot basic code
- Able to read schematics
- Experience with rapid prototyping (SLA, FDM, CNC)
MA: $93,039 - $123,277
Skills Required
- Bachelor's degree in Mechanical, Electrical, Biomedical, or Quality Engineering, or 3-4 additional years of trade experience
- 2-5 years of engineering experience within the medical device or regulated industry
- Working knowledge of ISO 13485, FDA QSR (21 CFR Part 820), and ISO 14971 risk management standards
- Direct experience planning and executing Verification and Validation for complex electromechanical devices
- Experience writing and executing Equipment IQ/OQ/PQ and Test Method Validation (TMV)
- Proficiency with data acquisition systems and analysis tools such as MATLAB or statistical software like Minitab
- Hands-on experience using mechanical test equipment such as tensile testers, gauges, and sensors
- Experience with endoscopic surgical laser systems
- Experience with surgical fluid irrigation/aspiration systems and components (pumps, pressure sensors, flow sensors)
- Experience testing polymer-based fluid delivery components or single-use medical disposables (biocompatibility, sterilization validation)
- SolidWorks or CAD proficiency for mechanical fixture design
- Experience coding data acquisition using Python or C, and ability to troubleshoot basic code
- Able to read schematics
- Experience with rapid prototyping (SLA, FDM, CNC)
IPG Photonics Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about IPG Photonics and has not been reviewed or approved by IPG Photonics.
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Equity Value & Accessibility — An Employee Stock Purchase Plan offers a 15% discount with a lookback feature and is available in the U.S. and Germany. This broad-based equity program is consistently highlighted as a standout component of total rewards.
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Leave & Time Off Breadth — PTO typically starts around three weeks with growth over tenure, alongside roughly 10–12 paid holidays and noted carryover options. Time-off policies are often viewed as a strong part of the package.
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Strong & Reliable Incentives — Annual bonuses are emphasized as a meaningful part of total compensation. Company materials and role descriptions explicitly include bonuses as part of the offering.
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The Company
What We Do
IPG Photonics is the world leader in fiber laser technology, offering solutions for applications across a wide array of industries. Headquartered in Marlborough, USA, the company has developed a robust, vertically integrated supply chain, developing key technology components in-house, thus enabling the most reliable, powerful, and efficient laser solutions. With over 30 locations across the globe, we are committed to developing innovative products that provide reliable, cost-effective solutions for our customers’ needs.
