Senior or Staff Manufacturing Engineer

BioTalent Ltd; Irvine (CA); On-site; USD 120,000 - 160,000; Full time

Job summary

BioTalent Ltd. seeks a hands-on engineering leader to own the technical launch of a new medical device production line in Irvine. You will drive design, setup, and qualification from specs through ramp-up, coordinating across Manufacturing, Quality, R&D and Supply Chain to ensure a successful line start.

The role demands a strong background in regulated manufacturing, ISO 13485, and process validation, with hands-on equipment experience and a track record of improving line efficiency.

Qualifications

• 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.

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

Skills

Manufacturing

Process engineering

DOE

SPC

Root Cause Analysis

Cross-functional comms

OEE

Lean/Six Sigma

Bottleneck analysis

Equipment commissioning

Education

Bachelor's in Mechanical/ Manufacturing/ Biomedical/ Industrial/ Electrical Engineering

Tools

Minitab

DOE tools

Job description

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