Staff Process Engineer - Design Transfer Center of Excellence

Integra LifeSciences • Princeton, NJ

2d • $109,250 - $149,500

About The Position

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 Process Engineer, Design Transfer - Operations Center of Excellence (CoE), reporting to the Director, Global Operations Excellence CoE, is a position responsible for establishing, governing, and scaling best‑in‑class manufacturing transfers and processes across a global life sciences manufacturing network. This role integrates design control, process development, process validation, and supplier/technology strategy to drive safe, compliant, scalable, and cost‑effective operations.

Requirements

• Bachelor's degree with 10+ years of experience or M.S with 7+ years of experience is required.
• Experience in the medical device industry is strongly preferred.
• Minimum of 5 years of Project Management experience is required, PMP certified preferred.
• A broad knowledge of manufacturing processes and subject matter expertise in specific manufacturing areas is required.
• Process expertise applicable to medical device manufacturing is strongly preferred.
• Design experience relating to manufacturing transfer of new products and knowledge of the full product life cycle is required, along with the ability to manage large/complex transfers with minimal oversight.
• Advanced knowledge in the application and selection of manufacturing processes with specific technologies is strongly preferred.
• Proficient knowledge of Process Excellence / Six Sigma statistical analysis techniques and its application in manufacturing processes is strongly preferred.
• Knowledge of GD&T standards is strongly preferred.
• Knowledge of how to execute GMPs, ISO 13485 Design Control, and manufacturing process IQ, OQ, PQ qualifications as related to medical devices is required.
• Strong technical communication skills and demonstrated ability to work independently with external suppliers is required.
• This position will require up to 10% travel.
• Strong organizational, interpersonal, and communication skills.
• Ability to present at management and leadership level meetings.
• Proficiency in MS Office Suite and statistical analysis software (ie minitab).
• Familiarity with health, safety, and environmental regulations related to manufacturing.
• Self-motivated team player with ability to work independently and collaboratively across all levels of the organization.
• Business understanding and wide systemic view
• High analytical skills – both financially and technically

Nice To Haves

• Master’s degree preferred.
• PMP certified preferred.
• Experience in the medical device industry is strongly preferred.
• Process expertise applicable to medical device manufacturing is strongly preferred.
• Advanced knowledge in the application and selection of manufacturing processes with specific technologies is strongly preferred.
• Proficient knowledge of Process Excellence / Six Sigma statistical analysis techniques and its application in manufacturing processes is strongly preferred.
• Knowledge of GD&T standards is strongly preferred.

Responsibilities

• Work in and lead cross-functional project teams including R&D, Quality, Supplier Quality, Procurement, Planning, Regulatory, and Manufacturing to develop and transfer surgical products for the neurosurgical medical device industry.
• Recognized manufacturing process technical expert who can independently provide engineering knowledge and oversight to plan and develop manufacturing processes, identify, spec, and procure mfg equipment, develop operation plans to support product development and transfer, resolve manufacturing- and quality-related problems, and interface with production facilities to act as the "Voice of Operations" on projects.
• Interprets internal/external manufacturing challenges and applies best practices to improve processes and capabilitities.
• Leading manufacturing transfer workstreams and teams, including developing and executing project plans and milestone, controlling / adjusting project plans; developing alternate pathways or options; identifying and mitigating technical and project risks; presenting project status to management, standardizing procedures across sites.
• Partnering with suppliers and internal manufacturing engineering teams to develop new processes and to refine current manufacturing processes, review output of those processes, and make corrections where needed to improve robustness. Review may include activities such as process mapping, sampling, controlled design of experiments and component inspections/test method development and validations.
• Provide leadership (technical and business) on critical supplier related programs, to ensure stable supply and support the overall supplier relationship.
• Developing and transferring control plans and monitoring processes at internal and external manufacturing sites to ensure processes are controlled and stable.
• Proactively and independently manages priorities based on changing needs; adjusts priorities to minimize impact to other business needs; communicates priorities as appropriate.

Benefits

• Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees