Senior Engineer, Quality Design Assurance

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

The Senior Engineer I, Quality Design Assurance, 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, be self‑motivated, 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. You will be able to independently plan and conduct projects and/or assignments with technical responsibilities or strategic inputs with moderately detailed instructions from leaders and stakeholders.

For this Sr I role, the ideal candidate will be a Subject Matter Expert with ISO 11607, 10993, and functional cascading system requirements to component drawings, balancing the use of Y 14.5 with the needs of the business.

• 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 (e.g., mistake proofing, critical control points, failure mode, effects analysis).
• Apply statistical methods and process/design excellence tools to establish test plans, evaluate test data and processes.
• Use DFSS techniques, process improvement techniques, and Lean process improvement techniques.
• Proficiency in Design/Process Verification and Validation, GR&R, Statistical Sampling Plan techniques, and Statistical Process Control.
• Conduct and support the development of test methods in equipment, process, and product qualifications/validations.
• Support transfer to manufacturing activities both in product development and base business.
• Contribute to root cause investigations using various problem‑solving techniques and tools and assess effectiveness of corrective actions.
• Develop inspection methodology and acceptance criteria for inspection sampling plans.
• Provide leadership in all areas of the Quality System, including Corrective & Preventive Actions, Risk Management, Complaints, Post‑Market Surveillance, Nonconforming Materials, etc.
• Fulfill design control requirements compliant with 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 in internal and external audits.
• Maintain the Quality System.

• Bachelor’s degree in engineering (Electrical/Electronic preferred; other disciplines such as Mechanical, Systems, Chemical considered).
• 5 years of experience working within a medical device or other regulated industry with knowledge of Risk Management (ISO 14971:2019), EU MDR, MDD, IEC 62366, ISO 13485 (Quality Management Systems), FDA QSR and cGMP.
• Strong analytical skills and a working knowledge of problem‑solving methodologies.
• Working knowledge of DFSS techniques,…