Staff Process Engineer - Change Control, Center of Excellence

Integra LifeSciences•Princeton, NJ

5d•Onsite

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, Change Control - Operations Center of Excellence (CoE), reporting to the Director, Global Operations Excellence CoE, is a position accountable for implementing, governing, and scaling best‑in‑class manufacturing change control processes across a global life sciences manufacturing network. This role integrates design control, change impact assessment, process validation and control, and PLM integration 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.
Minimum of 5 years of Project Management experience is required
A broad knowledge of manufacturing processes and subject matter expertise in specific manufacturing areas is required.
Design experience relating to manufacturing changes and knowledge of the full product life cycle is required, along with the ability to manage large/complex change projects with minimal oversight.
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.
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.
Experience in the medical device industry is strongly preferred.
PMP certified preferred.
Process expertise applicable to medical device manufacturing 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 with Enterprise compliance and Quality process lead to support the daily implementation of change controls to maintain processes that meet the compliance / regulatory guidance, while still allowing for effective and efficient integration into our operations.
Accountable for ongoing process improvements, productivity improvements, and for leveraging lean Six Sigma methodologies to identify and address inefficiencies across the enterprise.
SME resource that support the engineering teams during the actual daily usage as it applies to the changes within the manufacturing operations
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 capabilities.
Supporting change control 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 resolve process issues 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 process change projects to ensure stable supply and support the overall change implementation.
Supporting control plans and monitoring processes at internal and external manufacturing sites to ensure changes implemented 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.