Product Development Engineer II

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.
• Produces product development documentation in accordance with Good Documentation Practices.
• Documents work in laboratory notebooks and Technical Reports.
• Supports regulatory submissions as needed.
• Co-leads 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.

Requirements

• B.S. in Engineering or Science discipline or equivalent combination of education/experience.
• CAD training in Solid works and/or AutoCAD preferred.
• Minimum 4 years of relevant industry experience.
• Hands on experience 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

Pay range: $88K-$110K - Final compensation will depend on experience.