Limiting Uncertainty For The Busiest Surgeons
Sr Quality Engineer - Design and ReliabilityPrinceton, NJ
Integra LifeSciences is a global leader in regenerative technologies and neurosurgical solutions dedicated to limiting uncertainty for clinicians, so they can focus on providing the best patient care.
Founded in 1989, Integra develops, manufactures, sells and supplies best-in-class products to regenerate tissue, remove brain tumors, prevent infection and much more. And over the last three decades, we’ve evolved into one of the world’s leading global medical technology companies with more than 4,000 dedicated employees who deliver innovative medical technology solutions.
But that’s just the beginning. Integra is growing at an unprecedented rate. We’re at a moment in time where the experience you’ll gain is more robust than the experience you bring. And we’re out to invest in your future because it’s the best way to maximize ours.
At Integra, we firmly believe our people are our greatest asset and the foundation of our success. Our comprehensive Global Total Rewards program provides competitive compensation and benefits designed to keep our people healthy, motivated and engaged. Investing in our people through these programs is possible because of Integra’s ongoing commitment to our values and our shared success.
Integra’s health as a company begins with the well-being of our people. Benefit programs vary by country, whether provided through company-sponsored insurance and programs, through statutory government programs, or a combination of both.
Regardless of geographic location, our commitment is to offer the following, whenever possible:
• Benefit plans that meet all local statutory requirements
• A range of programs that reflect typical local market practices
• An opportunity for employees to tailor benefits to their specific needs
• Benefits that balance employee’s short-term and long-term needs
- Lead and support the design and development of new or improved products in close collaboration with Product Development, Project Management, RA, Marketing and Medical Affairs. Support Design Reviews, Technical Reviews, and Gate Reviews.
- Lead and support the execution of all Risk Management and Usability Engineering process activities, including design, process and application FMEAs.
- Support external partners in the development of products, including review and approval of development documentation such as product requirements, schematics, verification and validation strategy/execution
- Coordinate, review and approve development documentation created by external partners, including product requirements, schematics, code, verification and validation test strategy, protocols and reports.
- Develop Reliability models for predicting product performance over time.
- Lead implementation SPC programs with Manufacturing and Quality Control as a part of Process Validation and Design Transfer.
- Maintains knowledge of and applies statistical analysis to support data-driven decision making.
- Work with project teams to develop DOEs and statistically sound tests for appropriate support of results.
- Develop statistically based sampling plans for Design Verification and Validation, Process Validation, or other studies as deemed necessary.
- Participate in FDA inspections, ISO Certification and surveillance audits and customer audits as an NPD subject matter expert.
- Writing & coordinating efforts for the development and implementation of new and updated Quality System procedures for ISO/QSR, such as validation protocols, manufacturing procedures, product & material specifications, design & development documentation, SOPs, development and task force projects.
- Ensure that all projects are in compliance with GMP, QSR, ISO or other applicable requirements.
- Identify and implement opportunities for continuous improvement in the quality system.
- Interact and coordinate activities with other departments, external vendors and customers.
- Perform other Quality Systems related duties as required.
- Bachelors Degree in Engineering (Biomedical, Mechanical, or Electrical) or Science (Biology).
- 5 years of experience in a Quality Assurance role for medical device or pharmaceutical manufacturing.
- Demonstrates excellent knowledge of statistical sampling and analysis tools/methods to support data-driven decision making.
- Demonstrates excellent organizational, verbal and written communication skills
- Proficient with the MS Office Suite, and statistical software.
- Must be able to work independently with minimal supervision.
- Able to prioritize projects and manage assigned Quality resources to meet organizational goals and objectives.