Integra LifeSciences

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Quality Engineer III (Medical Device)

Quality Engineer III (Medical Device)

Vacancy ID 
Position Type 
Regular Full-Time
Quality Assurance

More information about this job


Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, reconstructive and general surgery, and regenerative wound care.


Integra's orthopedic products include devices and implants for foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair. Integra is a leader in neurosurgery, offering a broad portfolio of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care. Integra’s Tissue Technologies is an in-patient and outpatient Regenerative product portfolio, which includes products for wound care, burns, abdominal reconstruction, and plastic & reconstructive surgery.  In the United States, Integra is a leading provider of surgical instruments to hospitals, surgery centers and alternate care sites, including physician and dental offices.

Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has over 3,300 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."


The Senior NPD Quality Engineer will work within the Integra Lifesciences CSS Quality organization to support the development of new Medical Devices.


Working in the Design Quality team, you should excel in an environment that embraces teamwork, change, risk-based decision making and flexibility. You should be willing to make a significant contribution to a multi-discipline team, must be self-motivated to take actions, and have excellent written and verbal communication skills.  The position will support line extensions of existing products as part of the new product development process, as well as design related aspects of product and process transfers between manufacturing sites.


This position will have responsibility for new product introduction and development to ensure the highest levels of product quality to the end customer. Being able to independently plan and conduct projects and/or assignments with technical responsibilities or strategic inputs with moderately detailed instructions from Leaders and Stakeholders is a must-have.


    • 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. Perform Gage R&R studies.
    • 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 leadership abilities
    • Participate to internal and external audits.
    • Maintain the Quality System


  • Bachelor’s degree (or equivalent) in Engineering or related technical/scientific field with a minimum of 4 years of related experience.
  • Experience in medical device product development / process and product validation
  • Intermediate knowledge of Quality Engineering/Scientific methods and techniques.
  • Expertise in measurement techniques and sampling plan definition (for example, mechanical, optical, gages, automation).
  • Experience managing projects and demonstrating leadership abilities.
  • Strong analytical and statistical skills
  • Black Belt certification preferred
  • Knowledge of international Standards: ISO 9000, ISO 13485, ISO 14971, IEC 62304, IEC 60601 is preferred
  • Experience with Electrical safety testing is preferred
  • Experience in Capital Equipment including Software development and validation in regulated industry is preferred


The position is based in Mansfield, MA and requires up to 10% of domestic and international travel

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