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Staff Manufacturing Engineer
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What they do
A Manufacturing Engineer uses technology and engineering to help companies and organizations manufacture products with efficient use of time, resources, and energy.
$106,714 / year median in California
+6% projected growth
Job Description
Staff Manufacturing Engineer at BioTalent Staff Manufacturing Engineer at BioTalent in Aliso Viejo, California Posted in about 3 hours ago.
Type:
full-time 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