Staff Process Engineer – Change Control, Center of Excellence

Integra LifeSciences

Staff Process Engineer managing manufacturing change control processes at Integra LifeSciences. Responsible for implementing and scaling best-in-class manufacturing change control across a global network.

Posted 5/6/2026full-timePrinceton • California, Massachusetts, New Jersey, Utah • 🇺🇸 United StatesLead💰 $109,250 - $149,500 per yearWebsite

Tech Stack

Tools & technologies

PMP

About the role

Key responsibilities & impact

Work with Enterprise compliance and Quality process lead to support the daily implementation of change controls to maintain processes that meet compliance/regulatory guidance.
Accountable for ongoing process improvements, productivity improvements, leveraging lean Six Sigma methodologies.
SME resource that supports the engineering teams during actual daily usage regarding changes within the manufacturing operations.
Provide engineering knowledge and oversight to plan, develop manufacturing processes, identify and procure mfg equipment, develop operation plans, and resolve manufacturing- and quality-related problems.
Support change control workstreams and teams, including project plans and milestones, controlling/adjusting project plans.
Partner with suppliers and internal manufacturing engineering teams to resolve process issues and refine current manufacturing processes.

Requirements

What you’ll need

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, 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 changes and knowledge of the full product life cycle is required.
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.

Benefits

Comp & perks

medical
dental
vision
life insurance
short- and long-term disability
business accident insurance
group legal insurance
savings plan (401(k))

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Project ManagementLean Six SigmaStatistical AnalysisManufacturing ProcessesDesign ControlGD&TGMPsISO 13485Process ExcellenceProduct Life Cycle

Soft Skills

Technical CommunicationProblem SolvingCollaborationIndependenceProcess Improvement

Certifications

PMP