Staff Manufacturing Engineer

BioTalent; Irvine (CA); On-site; USD 150,000 - 190,000; Full time

Job summary

BioTalent is seeking a hands-on Manufacturing/Process Engineering Leader to own the technical launch of a brand-new medical device production line in Irvine. This role requires spearheading the entire lifecycle from specs through qualification and ramp-up, serving as the go-to technical owner for the line.

Ideal candidates will have 7–10+ years in manufacturing or process engineering, real experience standing up a new line for a regulated medical device, and strong skills in design transfer,

Qualifications

• Bachelor’s degree 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.
• Strong grasp of line design efficiency and line balancing.
• Hands-on with equipment specification, installation, commissioning, and process validation.
• Experience with DOE, SPC, process capability, and root-cause analysis.

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 design

Line balancing

DOE

SPC

Root-cause analysis

Cross-functional communication

OEE

Lean Six Sigma

Education

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

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!

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
• 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