Senior Engineer, Manufacturing
Core
Lead complex manufacturing improvement initiatives for Advanced Catheter production, focusing on yield stabilization, process capability, capacity expansion, and operational risk mitigation.
Role type
Senior Manufacturing Engineer (Medical Devices)
Builds
Advanced Catheter manufacturing operations and production lines
Domain
Medical device manufacturing (Cardiovascular)
Required skills
Lean Manufacturing, Six Sigma (DMAIC), Statistical Process Control (SPC), Design of Experiments (DOE), Root Cause Analysis, CAPA management, Process Validation, Equipment Qualification, Project Management, Risk Assessment, Technical Documentation
Preferred skills
FDA regulations knowledge, New Product Introduction (NPI), Change Control, Automated Production Systems, Cross-functional Leadership, Mentorship
Technologies
Microsoft Office Suite (Excel, PowerPoint, Project), CAPA systems, Audit tools
Responsibilities
Lead investigations and resolution of complex manufacturing, quality, and compliance issues; Design and execute rigorous engineering studies, experiments, and process validations; Mentor engineers and technicians in engineering best practices and data analysis; Develop and maintain manufacturing documentation, work instructions, and procedures; Support regulatory inspections, internal audits, and compliance initiatives; Collaborate with cross-functional teams to optimize manufacturing processes and achieve business objectives.
Seniority
Senior, hands-on IC with mentorship responsibilities