Staff Manufacturing Engineer

Note: This role requires direct experience standing up a brand-new manufacturing line from scratch — not transferring, optimizing, or scaling an existing line. Please confirm you meet this requirement before applying!

You'll 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

✅ 7-10+ 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