Engineer II, Manufacturing Process Engineering
Core
Develop, optimize, validate, and sustain manufacturing processes for mask products throughout their lifecycle within a regulated medical device environment.
Role type
Manufacturing Process Engineer
Builds
Mask manufacturing processes and equipment
Domain
Medical device manufacturing
Required skills
root cause analysis, process validation, process capability analysis, Lean Manufacturing, statistical tools, project execution
Preferred skills
Six Sigma, global product transfers, manufacturing scale-up, error-proofing
Technologies
IQ/OQ/PQ validation protocols, PFMEA, ISO 13485, FDA QSR, GMP
Responsibilities
Investigate and resolve manufacturing process and quality issues; Develop and optimize manufacturing processes to improve capability and productivity; Execute validation activities including Installation, Operational, and Performance Qualification; Lead root cause investigations and drive CAPA implementation; Collaborate with cross-functional teams to ensure safe and compliant production; Provide technical mentoring to graduate engineers and technicians.
Seniority
Mid-level, hands-on IC