Senior Engineer, Quality Design Assurance

Integra LifeSciences is a global medical technology leader in neurosurgery and regenerative medicine driven by our purpose of restoring patients’ lives. The company offers a broad portfolio of products and innovative solutions for dural access and repair, cerebral spinal fluid management and neuro-critical care. Its regenerative tissue technologies include products that address soft tissue, peripheral nerve and tendon repairs and for the treatment of acute and chronic wounds, burns, as well as for plastic and reconstructive surgery.

Founded in 1989 by Richard E. Caruso, the company is headquartered in Princeton, New Jersey. Today, Integra LifeSciences has grown immensely, with more than 4200 employees worldwide as well as offices, manufacturing and research facilities in Asia, Australia, Europe, Middle East, and the Americas.

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, 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, 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.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Primary responsibilities are to:

• 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

The requirements listed below are representative of the knowledge, skill and/or ability required for his position.

• A minimum BS degree in Engineering (Mechanical, Electrical, Systems) or related technical discipline with a minimum of 10 years of experience in related field is required. A Master’s or other advanced degree is a plus.

• DFSS certification required such as Green, or a Black Belts for Design. Green and/or Black belts for process improvement will be considered as well.

• Excellent problem solving, decision-making, and root cause analysis skills are required

• Interpersonal skills that foster conflict resolution as it relates to technical situations are required
• Previous experience in a medical device or a healthcare discipline is required
• Expert knowledge of Design Controls, GMPs, QSR, 21 CFR 820, MDD 93/42/EEC, ISO13485, IEC 62366, EU MDD/MDR and ISO14971
• Expert Quality Engineering skills with a proven track record in design optimization, verification, validation and design failure modes and effects analyses
• Knowledge of statistical methods, techniques, and their application to New Product Development
• Experience with Blueprint reading/literacy including GD&T is preferred
• Working knowledge of material science and mechanical product knowledge is preferred
• Product development and manufacturing experience is preferred
• Fluency in English is required.
• Proven track record of implementing Design Control and Engineering Practice continuous improvements to meet business goals.

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

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EEO Is the Law | EOE including Disability/Protected Veterans

Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA . If you have difficulty using our online system due to a disability and need an accommodation, please email us at [email protected].

Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.