2nd Shift Senior Manufacturing Engineer, Metals Processing
Core
Senior Manufacturing Engineer leading process improvement, yield optimization, and capacity expansion for critical implantable component manufacturing in a highly regulated medical device environment.
Role type
Senior IC manufacturing engineer (medical devices)
Builds
Implantable medical device components
Domain
Medical device manufacturing / Metals Processing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Statistical analysis, Lean Manufacturing, root cause analysis, process validation, equipment qualification, regulatory compliance, project management, technical leadership, cross-functional collaboration, data-driven decision making
Preferred skills
Lean Six Sigma certification, FDA regulations knowledge, CAPA systems experience, Design of Experiments (DOE), statistical process control (SPC), process capability analysis, hypothesis testing, new product transfer experience, automated production systems experience
Technologies
Microsoft Office Suite (Excel, PowerPoint, Project), CAPA systems, automated production systems
Responsibilities
Lead complex manufacturing improvement initiatives for yield stabilization and capacity expansion; Identify and implement process optimization opportunities using statistical analysis and Lean principles; Serve as technical leader and subject matter expert for manufacturing processes and equipment; Collaborate with cross-functional teams to improve manufacturing performance; Lead investigations and resolution of quality and compliance issues including CAPAs and audit observations; Design and execute engineering studies, process validations, and equipment qualifications; Mentor engineers and technicians in best practices and data analysis; Develop and maintain manufacturing documentation and work instructions.
Seniority
Senior, hands-on IC with technical leadership