JOB OVERVIEW
1. Contribute to the understanding and application of mechanical principles to the design and modification of intraocular lenses and their manufacturing.
2. Contribute to the understanding and application of mechanical principles to the design and modification of intraocular lens delivery devices and their manufacturing.
3. Lead design projects and perform the duties of a Design Project Manager.
4. Lead feasibility studies to investigate and assess new products and product amendments.
5. Assure that Design Control procedures are properly adhered to during development projects.
6. Execute product and process qualification protocols.
7. Set up and qualify manufacturing and research and development equipment as required.
8. Provide support with process optimization, process validation and troubleshooting production-engineering issues.
9. Provide engineering support to manufacturing.
10. Represents R&D on cross-functional teams.
11. Review Manufacturing and Quality Control Standard Operating Procedures to ensure adequacy. Participate in the generation of new procedures or the revision of existing procedures when needed.
12. Other duties as assigned.
EDUCATION & TRAINING
• Bachelor’s degree in Mechanical Engineering required, advanced degree preferred or equivalent combination of education/experience.
EXPERIENCE
• 5 years related experience is required.
• 2 years experience with medical devices, including early stage development.
SKILLS
• Good communication (written and verbal) and organizational skills.
• Self-starter and works well with others.
• Good analytical and problem-solving skills.
• Good manual dexterity and hands on development skills.
• Good basic computer knowledge (Excel, Word, etc.)
• Knowledge of Solid Works or similar CAD program.
• Good knowledge of mechanical design, analysis, and Finite Element Analysis.
• Demonstrated ability to work within the constraints of Design Control requirements.
• Demonstrated ability to write and perform validation and verification protocols.
STAAR Surgical is an equal opportunity employer.