A Manufacturing Engineer uses technology and engineering to help companies and organizations manufacture products with efficient use of time, resources, and energy.
Staff Manufacturing Engineer at BioTalent Staff Manufacturing Engineer at BioTalent in Corona Del Mar, California Posted in 8 days ago.
Type:
full-time
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 ? 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
