Senior Manufacturing Engineer at BioTalent Senior Manufacturing Engineer at BioTalent in Newport Coast, California Posted in 10 days ago.

Type:

full-time

Job Description:

•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 ???? 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 ? 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