Manufacturing Science - Monrovia, United States - STAAR Surgical

    STAAR Surgical
    STAAR Surgical Monrovia, United States

    3 weeks ago

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    Description

    JOB SUMMARY

    In support of the manufacture of STAAR products:

    1. Provide assistance in troubleshooting/resolving day to day manufacturing issues

    2. Identify, source, and pilot new equipment to support process improvements in manufacturing

    3. Create and execute validation protocols (IQ, OQ, PQ) and summarize test results as required

    4. Create and execute Test Method Validations (TMV) on measurement equipment

    5. Optimize process flow and eliminate non-value added steps in product handling; increase efficiencies; and reduce product lead time to Finished Goods Inventory.,

    6. Support and lead manufacturing design transfer activities for new products being introduced to production.

    7. Conduct root cause analysis for issues found in production

    8. Support open non-conforming material reports and CAPAs

    9. Liaise with relevant partners in order to drive continuous improvements in manufacturing.

    10. Lead facilities update projects to support manufacturing

    11. Review and approve process and engineering documents on behalf of Operations

    12. Other duties as assigned.

    EDUCATION & TRAINING

    Bachelors degree in technical discipline or equivalent combination of education/experience.

    Masters degree in a technical discipline a plus

    Lean/Six Sigma or similar training a plus

    EXPERIENCE

    Minimum of 5 years experience in a regulated industry.

    Design transfer experience preferred

    Clean room operations experience a strong plus

    Experience with CAD Design using SolidWorks Preferred

    Experience with Lens Optical Metrology Preferred

    Experience with Optical Lens Machining and Lensing Preferred

    Experience in the medical device industry and working with internal quality and regulatory teams preferred.

    Experience finding, qualifying, and working with manufacturing vendors preferred.

    Experience tracking and troubleshooting yield related issues using data analysis and statistical methods preferred.

    SKILLS

    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

    Working knowledge of requirements around IOLs or other Class III medical devices

    STAAR Surgical is an equal employment opportunity employer.