Senior or Staff Manufacturing Engineer
Listed on 2026-08-22
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Engineering
Manufacturing Engineer, Quality Engineering, Process Engineer, Validation Engineer -
Manufacturing / Production
Manufacturing Engineer, Quality Engineering, Validation Engineer
Technical Launch Manager For Medical Device Production Line
Own the technical launch of a brand-new medical device production line, from first specs through full qualification and ramp-up. This is a hands-on, high-visibility role for someone who wants to be the go-to technical owner for a line — not just a contributor to one.
Responsibilities:
Line specs, layout, capacity, cycle time, and staffing to meet business needs
Production builds — component availability, design configurations, special builds
Key production metrics: yield, scrap, throughput, cycle time, OEE, uptime, process capability
Design transfer from R&D into operations — bridging development through qualification and launch
Equipment procurement, installation, commissioning, and ramp-up
PFMEAs, control plans, process risk assessments, and validation protocols (IQ/OQ/PQ)
Continuous improvement, capacity expansion, and cost-reduction initiatives
Required Experience:
Bachelor's in Mechanical, Manufacturing, Biomedical, Industrial, or Electrical Engineering
5+ years in manufacturing or process engineering
Direct experience standing up and managing a new production line for a medical device — not just operating an already-mature line
Strong grasp of line design efficiency and line balancing (identifying bottleneck/slowest equipment, determining trade-offs on equipment speed)
Hands-on with equipment specification, installation, commissioning, and process validation
Strong grasp of DOE, SPC, process capability, and root-cause analysis
Comfortable owning cross-functional communication across Manufacturing, Quality, R&D, Ops, and Supply Chain
Medical device or other regulated manufacturing background
ISO 13485, process validation, and manufacturing risk management knowledge
Experience with automated assembly, dispensing, bonding, inspection, packaging, or test equipment
Lean/Six Sigma, OEE, PFMEA, and control plan experience
On-site in Irvine, CA — regular cleanroom work, with frequent commute to San Diego for business meetings
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