Process Engineer II
$99,500–$124,400 year
On-siteOntario, Canada
Job Summary
Independently evaluate manufacturing processes to propose, develop, and lead optimization measures that continuously improve capacity, yield rate, productivity, and cost-effectiveness. Manage industrialization for new high-technology products by coordinating equipment introductions and defining processes for both local R&D and global locations. Identify, plan, and execute initiatives guiding TPM teams, technicians, and production leads while performing equipment, process, and software validations. Author work instructions, inspection methods, and documentation, then train personnel on new procedures. Support CAPA projects and root cause analysis to investigate productivity or quality issues, providing guidance to junior team members. Contribute to global improvement projects by facilitating knowledge transfer between sister sites overseas and implementing digital and automated solutions on the manufacturing line.
Required Qualifications
- B.S. in Engineering
- 5+ years of manufacturing engineering experience
- experience supporting high-volume, fast-paced production environments
- Strong mechanical and hands-on technical experience
- Experience with process improvement
- troubleshooting
- root-cause analysis
- Ability to analyze data
- identify problems
- establish facts
- develop practical solutions
- Ability to read and interpret engineering drawings
- technical procedures
- specifications
- regulatory documentation
Desired Qualifications
- Experience in medical device or ophthalmic manufacturing
- Experience working in a cleanroom environment
- Experience in FDA Class III or other highly regulated manufacturing environments
- Knowledge of FDA/QSR
- GMP
- ISO 9000
- CE Mark
- ANSI
- U.S./international medical device regulations
- Hands-on experience with CNC
- lathes
- milling equipment
- Experience with Lean Manufacturing
- Six Sigma
- 5S
- Experience managing engineering projects
- Bilingual Spanish
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