Sr Process Development Engineer
Core
Primary engineering personnel supporting manufacturing operations for structural heart devices, accountable for line output, safety, yield, and quality.
Role type
Senior Manufacturing Process Engineer (Medical Devices)
Builds
Structural heart device manufacturing lines and management solutions
Domain
Healthcare / Medical Devices / Structural Heart
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Manufacturing/Process Engineering principles, Catheter assembly, Process Validations, Statistical analysis, 3-D drawing (Solidworks), Root cause analysis (DMAIC/A3), Regulatory compliance (US/non-US), Change management (CO/CR), Continuous improvement (CIP/CAPA), Equipment troubleshooting, NPI coordination
Preferred skills
Engineering management representation, Mentoring technical personnel, Cross-functional collaboration, Risk mitigation planning, Audit leadership
Technologies
Solidworks, eLHR system, Office applications (Word, PowerPoint, Excel)
Responsibilities
Identify product defects and determine operational/process actions to reduce defects; Perform on-line issue triage and generate corrective/preventative actions; Model/draft assemblies, fixtures, and tools; Support technicians in equipment availability issues; Execute line-related change management and generate CO/CRs; Lead root cause analysis for high-complexity manufacturing events; Coordinate product builds through the NPI process; Lead manufacturing engineering projects including CIPs, CAPAs, and Validations; Act as coach and mentor to less experienced engineers.
Seniority
Senior, hands-on IC with delegation authority potential