Principal/ Senior Manufacturing Process Engineer (Lifecycle Management)
Core
Establish, sustain, and optimize medical device assembly processes to improve safety, quality, delivery, productivity, cost, and regulatory compliance.
Role type
Senior Manufacturing Process Engineer (Lifecycle Management)
Builds
Medical device assembly processes and production readiness
Domain
Life sciences / Medical device manufacturing
Required skills
Lean manufacturing, process validation, root-cause analysis, Failure Mode and Effects Analysis, Design of Experiments, SAP, controlled documentation, jig and fixture design, regulatory compliance (ISO 13485)
Preferred skills
audit support, complaint investigation, supplier quality, corrective and preventive action, production training
Technologies
SAP
Responsibilities
Monitor First Pass Yield and process capability to implement corrective actions; Provide engineering support for new product design transfer and troubleshooting; Plan and execute process validation and qualification; Coordinate engineering changes and maintain production readiness; Develop standard work and manufacturing playbooks using Lean tools.
Seniority
Senior, hands-on IC