Mechanical Engineer – Perfect Lens, LLC – Irvine, CA

Perfect Lens is a medical device company developing the next-generation in lens customization for cataract patients. Perfect Lens is focusing on developing and manufacturing an in-vivo fine-tuning system for refractive index shaped Intraocular Lenses (IOL). This process requires changing the refractive index of the targeted IOL material with a femtosecond laser. Perfect Lens is changing the landscape of personnel care and customization of IOL’s. Be part of a company developing technology that will benefit millions with a better quality of life by improving their vision.

Perfect Lens is searching for a Mechanical Engineer who will be part of a team, developing an innovative Photonics medical device addressing an Ophthalmic opportunity. The Candidate will work closely with a small team and be responsible for leading mechanical design activities implementing innovative and cost-effective product solutions in order to support the organization from development through full-scale production. The candidate will have broad responsibilities and an opportunity to make a difference on a product that will serve millions.

The Candidate enjoys solving problems, embraces responsibility, thrives in a challenging environment, has a strong character when it comes to developing robust, safe, quality products, and Champions the Quality Process. You support Perfect Lens goal for meeting all regulatory compliance as a key member of the quality team you will help Perfect Lens gap the Quality Manual by developing SOP’s to address the evolution into a Production Company. After addressing Quality, the Candidate 10 years’ experience in designing and development fill focus on ramping up production. The Candidate should be well rounded and knowledgeable in matters such as; Document & Design Control, Design History Files, and travelers. Our goal is a robust, safe, and cost-effective medical device that is built correctly the first time and meets compliance.

Experience & Responsibilities;

Engineering;

• Learn and understand the applicable technology and engage in technical discussions
• Leads the transfer of Mechanical processes, process improvements, and products from development to production. Works to develop, sustain, and improve manufacturing processes
• Ability to facilitate and influence cross functional problem solving and process improvement
• Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors
• Participate with members of management in the design and development of products and analysis of customer requirements
• Participate and support product development activities; prototyping/testing, verification and validation testing
• Fact based problem solving, able to separate opinion from data
• Support and participate in project review phases (risk analysis)
• Produce detailed drawings in support of research, development, and production initiatives
• Develop and maintain product and process configurations and collaborate on the implementation of solutions
• Conduct in-depth troubleshooting
• Support validation projects from initial planning stages and throughout execution, review, and completion/approval of final reports.

Quality;

• Support of the ISO 13485 Quality System
• Ensure that design activities meet regulatory compliance
• Participate and support R&D team in quality control development and implementation
• Completes hands-on activities in areas of: Non-Conformance Resolutions, Evaluation of Process Changes and Design Changes.
• Identify non-conformances with requirements, provide suitable recommendations and facilitate ongoing quality improvements
• Investigate quality issues to ensure that proper changes are made to guarantee consistent quality

Other duties;

• Design and debug tooling for assembly, test, and manufacturing
• Document processes and work instructions
• Enclosures thermoforming
• Microsoft Office Application skills suitable for data analysis and reporting

Experience & Responsibilities;

• Attention to detail
• Medical device development
• 8-10 years industry experience
• Startup experience highly desirable
• Work successfully as a team-player
• Proactive, self-sufficient and a team player
• Experience with SolidWorks and mechanical design
• Working knowledge ISO 13485 Quality System Requirements
• Bachelor’s degree in Mechanical Engineering, or related technical field
• Strong work ethic and motivated to learn medical device quality control
• Excellent technical writing for preparing reports and supporting documentation
• Ability to apply past experience and knowledge to formulate new solutions to manufacturing process problems

How to apply

Candidates must be a United States Citizen or a permanent United States Resident.

We wish to thank all applicants for their interest and effort in applying for this position at Perfect Lens.

Job Type: Full-time

Required education:

• Bachelor’s