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.
Pay range: $88K-$110K - Final compensation will depend on experience.
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. #USA
STAAR, which has been dedicated solely to ophthalmic surgery for over 40 years, designs, develops, manufactures and markets implantable lenses for the eye. These lenses are intended to provide visual freedom for patients, lessening or eliminating the reliance on glasses or contact lenses. All of these lenses are foldable, which permits the surgeon to insert them through a small incision. STAAR’s lens used in refractive surgery is called an Implantable Collamer® Lens or “ICL,” which includes the EVO ICL™ product line. More than 3,000,000 ICLs have been sold to date and STAAR markets these lenses in over 75 countries. To learn more about the ICL go to: EVOICL.com. Headquartered in Lake Forest, CA, the company operates manufacturing and packaging facilities in Aliso Viejo, CA, Monrovia, CA and Nidau, Switzerland. For more information, please visit the Company’s website at www.staar.com.
