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 procedures.
2. Develops product specifications, manufacturing methods and procedures.
3. Conducts test protocols, verification and validation activities, and equipment qualifications.
4. Prepares test protocols and reports, verification and validation reports, and equipment qualification protocols. Responsible for producing product development documentation in accordance with Good Documentation Practice.
5. Provides leadership in product conceptualization and design and feasibility testing. Documents work in laboratory notebooks and Technical Reports.
6. Trains Manufacturing and Quality personnel in protocol execution, special test procedures as developed within R&D.
7. Assures that Design Control and other procedures are properly adhered to during product development projects.
8. Reviews Manufacturing and Quality Control Standard Operating Procedures to ensure adequacy.
9. Represents R&D on cross-functional teams that are working on Quality-related projects.
10. Other duties as assigned.
EDUCATION & TRAINING
- B.S. in Engineering or Science discipline. Masters degree preferred but equivalent combination of education/experience acceptable.
- Minimum 10 years industry experience or equivalent.
- Minimum 5 years in medical device industry.
- Knowledge of Design Control procedures and Quality systems.
- Demonstrated experience developing and transferring new products.
- Strong background in engineering techniques and methodologies.
- Good analytical and problem-solving skills.
- Knowledge of and ability to follow Design Control requirements.
- Knowledge of validation and verification techniques.
- Self-starter and works well with others.
- Good communication and organizational skills.
- Working knowledge of Solid Works, CAD or AUTOCAD preferred.
- Knowledge of the science of polymers and/or plastics preferred.
- Independent thinking in order to solve engineering problems.
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.