Senior Manufacturing Process Engineer
Core
Lead manufacturing equipment initiatives and drive quality, productivity, and cost improvement projects for diagnostic testing operations.
Role type
Senior Manufacturing Process Engineer
Builds
Manufacturing processes, equipment, and validation protocols for diagnostic devices
Domain
Healthcare diagnostics / Regulated manufacturing
Required skills
Process optimization, Design for Manufacturability (DFM), DOE methodologies, Equipment qualification (IQ/OQ/PQ), Root cause analysis, Regulatory compliance (FDA/cGMP), Statistical analysis, Change management, Technical documentation, Cross-functional collaboration, Mentorship
Preferred skills
cGMP experience, ISO 13485 knowledge, Statistical software (Minitab/JMP)
Technologies
Agile PLM/PDM, Microsoft Office (Excel, PowerPoint, Power BI), CAD, Minitab, JMP
Responsibilities
Own and maintain manufacturing processes aligned with product specifications; Lead process and equipment improvement initiatives; Evaluate and implement manufacturing alternatives using DFM principles; Solve complex technical challenges using statistical tools; Design and execute engineering studies including DOE; Lead equipment implementation, startup, and validation; Ensure compliance with FDA, ISO, and cGMP requirements; Support Quality Incidents and CAPA investigations; Analyze raw material specifications and lead validation activities; Develop and maintain manufacturing documentation (SOPs, protocols, risk assessments); Conduct audits for regulatory and operational standards; Lead technical reviews for equipment and process changes; Research and implement new manufacturing technologies; Drive change management through PLM systems; Mentor engineers and technicians.
Seniority
Senior, hands-on IC