Integra LifeSciences · 4 months ago
Sr Design & Reliability Assurance Quality Engineer
US-MA-Mansfield-190-Facility
Full-time
Onsite
Senior LevelIntegra LifeSciences is a company focused on innovating new treatment pathways to advance patient outcomes in healthcare. The Sr Design & Reliability Assurance Quality Engineer will lead and support the design and development of medical devices, conduct risk analysis, and ensure compliance with quality systems and regulatory standards.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
Lead and/or support the design and development of medical devices in close collaboration with R&D and external partners, including software requirements and electrical/software architectures
Lead and/or support risk analysis activities (FMEAs and SHAs). Demonstrate proficiency in applying various risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure mode, effects analysis)
Apply statistical methods and process/design excellence tools to establish test plans as well as evaluate test data and processes
Proficiency in Design / Process Verification and Validation, GR&R, Statistical Sampling Plan techniques, and Statistical Process Control
Conducts, and supports the development of test methods in equipment, process, and product qualifications/validations
Support transfer to manufacturing activities both in product development and base business
Contributes to root cause investigations using various problem-solving techniques and tools, and assesses effectiveness of corrective actions
Develop inspection methodology and acceptance criteria for inspection sampling plans
Provide leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Risk Management, Complaints, Post Market Surveillance, Nonconforming Materials, etc
Fulfill design control requirements compliant: software specifications, detailed design files, design verification and validation test plans, risk management, DHF, protocols, and reports in accordance with company procedures, FDA and ISO guidelines
Support Design and Technical Review
Communicate effectively at all levels within Quality, as well as cross functionally with departments such as Research & Development, Regulatory, Marketing and Manufacturing
Demonstrate project management and leadership abilities
Participate to internal and external audits
Maintain the Quality System
Qualification
Required
Lead and/or support the design and development of medical devices in close collaboration with R&D and external partners, including software requirements and electrical/software architectures
Lead and/or support risk analysis activities (FMEAs and SHAs). Demonstrate proficiency in applying various risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure mode, effects analysis)
Apply statistical methods and process/design excellence tools to establish test plans as well as evaluate test data and processes
Proficiency in Design / Process Verification and Validation, GR&R, Statistical Sampling Plan techniques, and Statistical Process Control
Conducts, and supports the development of test methods in equipment, process, and product qualifications/validations
Support transfer to manufacturing activities both in product development and base business
Contributes to root cause investigations using various problem-solving techniques and tools, and assesses effectiveness of corrective actions
Develop inspection methodology and acceptance criteria for inspection sampling plans
Provide leadership in all areas of the Quality System, including, but not limited to Corrective & Preventive Actions, Risk Management, Complaints, Post Market Surveillance, Nonconforming Materials, etc
Fulfill design control requirements compliant: software specifications, detailed design files, design verification and validation test plans, risk management, DHF, protocols, and reports in accordance with company procedures, FDA and ISO guidelines
Support Design and Technical Review
Communicate effectively at all levels within Quality, as well as cross functionally with departments such as Research & Development, Regulatory, Marketing and Manufacturing
Demonstrate project management and leadership abilities
Participate to internal and external audits
Maintain the Quality System
Company
Integra LifeSciences
Integra LifeSciences is an integrated medical device company.
Founded in 1989
1001-5000 employees
H1B Sponsorship
Integra LifeSciences 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 (4)
2024 (5)
2023 (4)
2022 (7)
2021 (5)
2020 (4)
Funding
Current Stage
Public CompanyTotal Funding
$350M2018-05-15Post Ipo Equity· $350M
1995-08-25IPO
Leadership Team
Mojdeh Poul
Chief Executive Officer
Lea Knight
EVP and Chief Financial Officer
Recent News
Integra LifeSciences Holdings Corporation
2025-12-02
Company data provided by crunchbase