Manufacturing Engineering Manager
On-sitePonte Vedra, Florida, United States
Job Summary
Lead the Technician team by guiding day-to-day manufacturing operations, providing leadership support, and coaching staff to foster a positive culture. Manage design transfer activities from R&D to production while collaborating with cross-functional teams to optimize designs for manufacturability and ensure biological safety compliance per ISO 10993 standards. Develop and implement high-quality manufacturing processes, resolve production issues hands-on, and support validation protocols including IQ, OQ, and PQ. Collaborate with suppliers to ensure component reliability and assist in identifying new suppliers for compliant manufacture. Requires 8+ years of mechanical design experience, knowledge of FDA and ISO regulations, and willingness to travel 10-30% for supplier visits.
Required Qualifications
- Bachelor's degree in mechanical design or closely related field
- 8+ years of relevant mechanical design and manufacturing engineering experience
- Strong knowledge of design transfer processes, design for manufacturability (DFM)
- Experience working in a regulated environment (FDA, ISO 13485), Risk Management ISO 14971, and biological safety per ISO 10993 standards
- Knowledge of Lean Manufacturing principles and Six Sigma methodologies
- Experience with Microsoft applications (Word, Excel, Outlook)
- Must be willing to travel 10-30% of the time for supplier visits, process troubleshooting, etc.
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