Manufacturing Process Engineer
Core
Develop, validate, and sustain manufacturing processes and equipment to ensure product quality, regulatory compliance, and operational efficiency in a medical device environment.
Role type
Manufacturing Process Engineer
Builds
Robust, compliant, and scalable manufacturing processes for medical devices
Domain
Medical device manufacturing / Industrial Engineering
Required skills
Process validation, PFMEA, statistical analysis, Lean Manufacturing (Kaizen, DMAIC, 5S), root cause analysis (5 Why, Fishbone), SOP creation, NPI support, cross-functional collaboration
Preferred skills
Six Sigma, statistical process control, mentoring junior engineers, data-driven decision making
Technologies
PFMEA, DMAIC, 5 Why, Fishbone Analysis, ISO 13485, GMP
Responsibilities
Develop and qualify manufacturing processes and tooling; Conduct process risk assessments and implement mitigation strategies; Lead process validation and ensure regulatory compliance; Investigate deviations and implement CAPA; Drive continuous improvement initiatives; Support New Product Introduction (NPI) and Design for Manufacturability; Monitor performance metrics and resolve bottlenecks; Provide technical guidance and training to operators and teams.
Seniority
Mid-Senior, hands-on IC
