Process Engineer 3
Core
Lead manufacturing process improvements, production controls, and efficiency initiatives while supporting new product introductions and ensuring compliance in an FDA-regulated environment.
Role type
Senior IC process engineer (manufacturing)
Builds
Manufacturing processes, production controls, and equipment qualifications
Domain
Medical devices / Life Sciences
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process engineering, risk assessment, change control, validation protocols, equipment qualification, new product transfer, user needs documentation, R&D feasibility evaluation
Preferred skills
Cross-functional collaboration, cost-saving initiatives, technical leadership
Technologies
MS Office (Word, Excel, PowerPoint)
Responsibilities
Lead development and implementation of manufacturing process improvements, drive risk and gap assessments, oversee equipment and process qualifications, author and review quality system documentation, support new product transfers, qualify new manufacturing equipment, partner on cost-saving opportunities, conduct R&D activities, provide technical support across operations
Seniority
Senior, hands-on IC
