MAIN JOB RESPONSIBILITIES / COMPETENCIES
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.
Develops product specifications, manufacturing methods and procedures under general guidance.
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.
Supports regulatory submissions as needed.
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.
Manages procurement of new equipment including sourcing new suppliers
Performs hands-on laboratory experiments and conducts data analysis
Other duties as assigned
REQUIREMENTSEDUCATION & 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.
STAA R 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 30 years, designs, develops, manufactures and markets implantable lenses for the eye with companion delivery systems. 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". More than 700,000 Visian ICLs have been implanted to date.
To learn more about the ICL go to: discovervisianicl.com. STAAR has approximately 360 employees and markets lenses in over 60 countries. Headquartered in Monrovia, CA, the company operates manufacturing facilities in Aliso Viejo, CA and Monrovia, CA.