Test Engineer

IPG Photonics Corporation

Marlborough (MA)

On-site

USD 75,000 - 87,000

Full time

5 hours ago

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Benefits offered by this job

Medical, dental, and vision insurance

401(k) plan with company matching

Tuition reimbursement

Employee Stock Purchase Plan (ESPP)

Paid time off

Job summary

IPG Photonics Corporation in Marlborough, MA is seeking a Verification and Validation Test Engineer to design, build, and validate test methods for medical devices in an ISO 13485 and FDA QSR compliant environment.

You will support R&D through Production, author protocols and data sheets, and apply statistical methods to assess performance. This role requires 1–3 years in a medical device or regulated industry and working knowledge of ISO 13485, FDA QSR, and ISO 14971 risk management standards.

Qualifications

Bachelor’s degree in Mechanical, Electrical, Biomedical, or Quality Engineering.
1–3 years of engineering experience within the medical device or regulated industry.
Working knowledge of ISO 13485, FDA QSR, and ISO 14971 risk management standards.
Direct experience in planning and/or execution of Verification and Validation for complex electrotechnical devices.
Proficiency with data acquisition systems, and proficiency in analysis tools such as Excel and Python, or statistical software like Minitab.
Hands-on experience using mechanical test equipment like tensile testers, gauges, and sensors.

Responsibilities

Execute Design Verification and Validation activities for complex electromechanical devices and single-use disposables.
Design, develop, validate and execute test methods to inform design decisions and verify system functionality.
Author test protocols, data sheets, and final reports; author/assist manufacturing procedures and machine instructions.
Ensure all activities align with ISO 13485, FDA 21 CFR Part 820, and risk management standards.
Apply statistical techniques like ANOVA, Gage R&R, and capability analysis to test datasets.
Present test findings to stakeholders and communicate risk and countermeasure insights.

Skills

Data acquisition

Statistical analysis

Python

Excel

Minitab

Lab equipment

Education

Bachelor’s degree in Mechanical, Electrical, Biomedical, or Quality Engineering

Tools

Data acquisition systems

Python

Excel

Minitab

Linux

Job description

Marlborough, Massachusetts, United States

Job Description

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.

Requirements

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.

Location(s)

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

Employment Type

Exempt

Wage Information

MA: $74,956 - $87,136

US Benefits Information

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: