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Product Development Engineer II
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STAAR SURGICAL
Tustin, CA (In Person)
$99,000 Salary, Full-Time
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Job Description
MAIN JOB RESPONSIBILITIES / COMPETENCIES 1.
Performs activities associated with the development of new ophthalmic lenses and delivery systems and supports existing products and processes in accordance with Design Control and Risk Management procedures. 2. Develops product specifications, manufacturing methods and procedures under general guidance. 3. Supports design project activities, from concept to design transfer, collaborating with cross functional teams. Including producing product development documentation in accordance with Good Documentation Practices. Documents work in laboratory notebooks and Technical Reports. 4. Support regulatory submissions as needed. 5. Co-lead design verification and design validation activities, equipment qualifications (e.g.IQ/OQ/PQ
), Test method development and validation including generation of test protocols/reports and test execution. 6. Manages procurement of new equipment including sourcing new suppliers 7. Performs hands-on laboratory experiments and conducts data analysis 8. Other duties as assigned.REQUIREMENTS EDUCATION & TRAINING
- B.S. in Engineering or Science discipline or equivalent combination of education/experience.
- CAD training in Solid works and/or AutoCAD preferred.
EXPERIENCE
- Minimum 4 years of relevant industry experience.
- Hands on experienced in Design Control procedures and Quality systems.
- Hands on experience developing and transferring new products, including Design Verification & Validation, and Equipment Qualification SKILLS
- Good analytical and problem-solving skills.
- Knowledge of and ability to follow Design Control requirements.
- Knowledge of qualifications, validation and verification techniques.
- Independent execution of design, analysis, or product development tasks
- Understanding of biocompatibility, sterilization, and packaging.