IPG Photonics · 3 months ago
Sr Design Assurance Engineer
Marlborough, MA, 01752, United States
Full-time
Onsite
Senior LevelIPG Medical Corporation is focused on developing next-generation medical products based on its state-of-the-art technology. The Senior Design Assurance Engineer plays a critical role in ensuring that IPG’s medical device products meet regulatory requirements, quality standards, and customer expectations, providing technical expertise and leadership in design controls, risk management, and compliance testing throughout the product lifecycle.
ElectronicsIndustrial ManufacturingLaserManufacturing
Responsibilities
Lead and conduct product design control activities for both new product development and sustaining engineering projects
Support risk analysis activities, including development and maintenance of design and process FMEAs
Partner with cross-functional teams to support design and process validation/verification activities, including software validation and IQ/OQ/PQ protocols
Collaborate with Design Engineering to create and maintain Design History Files and Technical Files
Coordinate with third-party test houses to ensure compliance testing for IPG products is properly executed and documented
Assist the Regulatory Affairs department in preparing FDA, CE, and other global regulatory submissions
Ensure adherence to applicable regulatory requirements, company policies, and quality standards
Perform other essential duties as assigned to support departmental and organizational objectives
Qualification
Required
Deep knowledge of medical device regulations and standards
Strong analytical skills
Ability to balance technical detail with strategic quality objectives
Experience in product design control activities for new product development and sustaining engineering projects
Experience in risk analysis activities, including development and maintenance of design and process FMEAs
Experience in design and process validation/verification activities, including software validation and IQ/OQ/PQ protocols
Experience in creating and maintaining Design History Files and Technical Files
Experience in coordinating with third-party test houses for compliance testing
Experience in preparing FDA, CE, and other global regulatory submissions
Knowledge of applicable regulatory requirements, company policies, and quality standards
Benefits
Competitive benefits
Company
IPG Photonics
IPG Photonics develops and manufactures fiber lasers and amplifiers for diverse applications in numerous markets.
Founded in 1990
1001-5000 employees
H1B Sponsorship
IPG Photonics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (6)
2023 (5)
2022 (6)
2021 (7)
2020 (7)
Funding
Current Stage
Public CompanyTotal Funding
$80MKey Investors
TA Associates
2006-12-13IPO
2000-12-13Series Unknown
2000-09-21Series B· $80M
Leadership Team
Mark Gitin
Chief Executive Officer
Mira Sahney
Senior Vice President, Global Laser Systems and President IPG Medical
Recent News
GlobeNewswire
2025-12-15
2025-11-07
Company data provided by crunchbase