Validation/ Project Engineer-PAL0003
Who We AreSightGlass Vision, Inc., a subsidiary of CooperVision and is in a pending Joint Venture with Essilor, is the inventor and manufacturer of novel spectacle lenses that have proven to strongly reduce the progression of nearsightedness in children. With this game-changing technology, we are poised to improve the life of millions of children worldwide. The SightGlass Vision office is located in the heart of Silicon Valley, in Palo Alto, California. This position is remote.
CooperVision, a division of CooperCompanies (NYSE:COO), has a strong heritage of solving the toughest vision challenges such as astigmatism, presbyopia and childhood myopia. Through a combination of innovative products and focused eye care practitioner support, the company brings a refreshing perspective to the marketplace, creating real advantages for customers and wearers. For more information, visit www.coopervision.com
Why Work With UsWe are a small but growing enthusiastic team and as such we recognize each employee as a vital member of the team. Integrity and respect are fundamental to our working relationships. We have a nimble start-up mentality, and are backed by the world leaders in vision care products. We are friendly, inventive, and dedicated. We don’t quit until the job is done right! Our lenses don’t just change vision, they change lives. Join a team that is passionate about improving children’s visual health and quality of life.
Job Summary:We are seeking a Talented Validation/Project Engineer who is has great communication skills and is excited to work with us! As the Validation/Project Engineer you will bed tasked with developing and executing validation activities in compliance with ISO 13485 and 21 CFR Part 820 requirements to assist in the global rollout of the manufacturing processes developed in Palo Alto. Additionally, we are looking for someone who can assist in project identification and execution for new engineering projects. The Validation/Project Engineer Will also be expected to assist in the maintenance and production of engineering drawings as needed.
Essential Functions & Accountabilities:
- Identify equipment / process qualification requirements, including writing requirements documentation, as necessary.
- Validate/Verify and implement medical device manufacturing processes as assigned. This may contain:
- Prepare and maintain accurate documentation and work instructions consistent with the requirements of pertinent regulations and Company’s Quality Management System where applicable.
- Written preparation of applicable validation reports that meet regulatory/company standards.
- Run qualifications – IQ / OQ / PQ / Process Validation / Verification Testing
- Project management – Identify areas of improvement in the manufacturing process and lead projects to implement improvements. Share knowledge across the team, leading small groups thru projects.
- Works closely with Regulatory Affairs, Research and Development, Manufacturing, Clinical and other functional groups, to ensure compliance to applicable standards (external and internal) such as ISO 13485, ISO 14971, and FDA QSR/GMP.
- Adhere to Standard Operating Procedures and Regulatory requirements.
- Performs other related duties and responsibilities, as assigned.
- Travel: Up to 40% depending on needs. May include both domestic and international destinations
Qualifications, Knowledge, Skills and Abilities:
- Technically sound in quality systems and be abreast of developments in the Quality Assurance field. Including practical application of ISO 13485 and/or FDA Quality System Regulation 21 CFR part 820.
- Experienced with writing / running qualifications (IQ/PQ/OQ/process validation) in a regulated manufacturing environment. (ISO 13485 experience preferred)
- A self-starter and able to work both independently and as a leader of an integrated, interdisciplinary team in carrying out assigned responsibilities.
- Positive attitude, strong work ethic and self-motivated. Ability to handle multiple projects simultaneously and work with minimal supervision.
- Ability to create and maintain engineering drawings, as needed.
- Ability to remain calm and receptive in fast paced situations.
- Proficient in Microsoft Office tools.
- Individual must be able to sit and work in front of a computer for long periods of time.
- The employee may be intermittently exposed to moderate noise levels.
- Ability to lift up to 30 lbs.
- Must be able to travel periodically both domestically and internationally
- Minimum of three years engineering experience in a regulated industry, preferably in a medical device manufacturing environment; five years preferred.
- Ability to contribute and collaborate in a creative, fast-paced and team-oriented environment.
- Excellent problem-solving skills.
- Solidworks or equivalent CAD design experience
- Bachelor's degree in Engineering or Engineering Technology or related discipline.
Affirmative Action/Equal Opportunity Employer. Minority/Female/Disability/Veteran
Primary Location:United States-California-Palo Alto
Organization:CVI Sightglass Vision