Manufacturing Science &Technology Engineer II
About The Position
In support of the manufacture of STAAR products, this role involves troubleshooting manufacturing issues, piloting new equipment for process improvements, creating and executing validation protocols (IQ, OQ, PQ), and summarizing test results. The position also requires creating and executing Test Method Validations (TMV) on measurement equipment, optimizing process flow to increase efficiencies and reduce lead times, and supporting design transfer activities for new products. Additionally, the role includes conducting root cause analysis for production issues, supporting non-conforming material reports and CAPAs, liaising with partners for continuous improvement, leading facilities update projects, and reviewing/approving process and engineering documents on behalf of Operations. Other duties as assigned.
Requirements
- Bachelor’s degree in technical discipline or equivalent combination of education/experience.
- Minimum of 5 years experience in a regulated industry.
- Demonstrated understanding of, and ability to practically implement, cGMP/QSR/ISO requirements
- Excellent team building and interpersonal skills
- Excellent prioritization, multi-tasking and organizational skills
- Ability to lead cross-functional teams to execute projects to planned timeline
- Well versed in lean manufacturing and process improvement
Nice To Haves
- Master’s degree in a technical discipline a plus
- Lean/Six Sigma or similar training a plus
- Design transfer experience preferred
- Clean room operations experience a strong plus
- Design experience using CAD or related software preferred.
- Working knowledge of requirements around IOL’s or other Class III medical devices
Responsibilities
- Provide assistance in troubleshooting/resolving day to day manufacturing issues
- Identify, source, and pilot new equipment to support process improvements in manufacturing
- Create and execute validation protocols (IQ, OQ, PQ) and summarize test results as required
- Create and execute Test Method Validations (TMV) on measurement equipment
- Optimize process flow and eliminate non-value added steps in product handling; increase efficiencies; and reduce product lead time to Finished Goods Inventory.
- Support and lead manufacturing design transfer activities for new products being introduced to production.
- Conduct root cause analysis for issues found in production
- Support open non-conforming material reports and CAPAs
- Liaise with relevant partners in order to drive continuous improvements in manufacturing.
- Lead facilities update projects to support manufacturing
- Review and approve process and engineering documents on behalf of Operations
- Other duties as assigned.
Benefits
- STAAR Surgical is an Equal Opportunity/Affirmative Action employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran or disability status, or any other characteristic protected by law.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
