Senior Manufacturing Engineer

BioTalent; Irvine (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

BioTalent in Irvine, CA is seeking a Senior/Staff Manufacturing Engineer to 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.

This role requires coordinating across Manufacturing, Quality, R&D, Ops, and Supply Chain to design line specs, equipment, and validation plans while

Qualifications

• Bachelor's degree in engineering as listed
• 5+ years in manufacturing or process engineering
• Experience launching or scaling manual or semi-automated production lines
• Hands-on with equipment specification, installation, commissioning, and process validation
• Strong grasp of DOE, SPC, process capability, and root-cause analysis
• 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

Responsibilities

• Line specs, layout, capacity, cycle time, and staffing to meet business needs
• 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

Skills

Line launch

Root cause analysis

Cross-functional communication

OEE

Education

Bachelor's in Mechanical Engineering

Bachelor's in Biomedical Engineering

Bachelor's in Manufacturing Engineering

Tools

IQ/OQ/PQ

PFMEA

Job description

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!

*Senior or Staff level depending on experience

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
• 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
• Experience launching or scaling manual or semi-automated production lines
• 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