We are currently partnering with a leading medical packaging manufacturer who are seeking an Integration Engineer to join their team based in Trevor, WI.
The Integration Engineer is responsible for guiding and supporting process validation and manufacturing integration activities for medical device packaging, flexible film converting, and related manufacturing processes. This role ensures manufacturing processes are developed, validated, transferred, and maintained in compliance with FDA Quality System Regulation (21 CFR Part 820), ISO 13485, customer requirements, and internal quality standards.
The engineer will work cross-functionally with Operations, Quality, Design Engineering, and customers to support new product introductions, process improvements, equipment qualifications, and ongoing manufacturing validation activities.
Responsibilities:
- Develop and execute IQ, OQ, and PQ validation protocols and reports.
- Lead validation activities for flexible film converting, RF welding, heat sealing, pouch manufacturing, printing, and labeling operations.
- Perform process capability studies and statistical analysis to support validation activities.
- Support new product introductions (NPI) from concept through commercial production.
- Identify and implement process improvements focused on quality, efficiency, scrap reduction, and throughput.
- Lead root cause investigations and corrective actions related to process performance.
- Ensure compliance with FDA 21 CFR Part 820 / QMSR, ISO 13485, GMP requirements, and customer-specific quality requirements.
- Develop and manage project timelines, deliverables, and validation schedules to support customer and internal milestones.
- Coordinate activities between Engineering, Quality, Operations, Supply Chain, and customer teams to ensure successful project execution.
- Serve as a primary technical point of contact for customers during new product introductions, validation activities, process transfers, and ongoing manufacturing support.
- Communicate project status, technical risks, validation progress, and issue resolution plans to internal leadership and customers.
- Facilitate customer meetings, technical reviews, and validation planning discussions.
- Support quotation reviews and provide technical input related to manufacturability, process capability, and validation requirements.
- Support customer visits, audits, factory acceptance activities, and production trials as needed.
Requirements:
- Bachelor’s degree in Engineering or related technical field required.
- 3+ years of engineering experience in a regulated manufacturing environment.
- Experience with process validation in regulated manufacturing.
- Working knowledge of IQ/OQ/PQ methodologies, statistical analysis, root cause analysis tools, and risk management methodologies.
- Knowledge of FDA 21 CFR Part 820 and ISO 13485 requirements.
- Experience with RF welding, heat sealing, extrusion, laminating, pouch manufacturing, or printing technologies.
- Experience with EQMS systems.