What are the responsibilities and job description for the Senior Engineer, Manufacturing (ME) position at Glaukos Corporation?
The position of Senior Manufacturing Engineer is responsible for supporting manufacturing by developing, qualifying, implementing and maintaining manufacturing equipment, processes and procedures. This individual will develop and lead projects to improve process efficiencies and cost savings.
***Please note, Glaukos compensation ranges were not directly given to LinkedIn and are estimated ranges from similar roles. Glaukos provides competitive industry and functional compensation. Please apply and inquire with your recruiter.***
Job Requirements:
- Support existing manufacturing product lines.
- Lead, coordinate and execute product, design and/or technology transfers.
- Serve as technical expert for existing products/processes as well as product transfers.
- Develop specifications and procedures for manufacturing, test and inspection processes.
- Develop and execute test protocols (IQ, OQ, PQ), author test reports, technical memos, investigations and document changes in accordance with regulatory and corporate requirements.
- Design, develop, qualify, and validate manufacturing processes and tooling/equipment.
- Assist in the selection and qualification of vendors for the procurement of production materials and equipment.
- Perform root cause analysis. Develop and implement corrective actions.
- Participate in design reviews representing manufacturing as required
- Maintains working knowledge of company policies and procedures, ISO and FDA requirements.
Experience Requirements:
- Bachelor's degree in an engineering discipline, preferably mechanical or electrical.
- 8 years experience in a manufacturing environment in a regulated industry, medical device required.
- Experience with electro-mechanical assembly, mechanical assembly, PCBA's and cables
- Ability to converse with vendors to resolve issues
- Familiarity with FDA regulatory requirements, GMP, ISO, lean, process validation and six sigma methodologies.
- Experience working closely with design engineering, quality engineering and production personnel.
- Demonstrated ability to gather, analyze and evaluate data as well as recommend actions.
- Knowledgeable in troubleshooting electro-mechanical systems.
- Ability to read and understand mechanical drawings and electrical schematics.
- Computer skills: Word, Excel, Powerpoint.
Additional Desirable Qualifications Skills and Knowledge:
- PFMEA/Risk analysis.
- Fixture design experience (Mechanical, Electrical, Optical)
- Proficiency using Solidworks Composer, Experience with optics design and fixturing
- Excellent verbal and written communication skills.
- Understanding of technical/scientific challenges as they apply to the production processes in both Drug Substance and Drug Product Manufacture.
- Exposure to aseptic manufacturing operations, and/or drug product manufacturing
- Reliability test development
Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible. These are just a few of the terms our employees use to describe their experiences as a part of the Glaukos family.
Those may seem like big aspirations, but here at Glaukos, we recognize the deep significance and profound meaning that comes from knowing that we can make a meaningful difference by helping improve eyesight of people worldwide. And because we're a rapidly growing company with a dynamic, fast-paced culture, individual employees here are empowered with more diverse and enriching challenges than might not be possible at a larger company, and more fulfillment in knowing every person and every task is directly tied to making a difference in the life of others.
We offer competitive salary (based on experience), bonus eligibility, medical/dental/vision, life insurance, stock options, 401(k) Employer Match, Employee Stock Purchase Program, trackless paid time off & paid holidays as well as time-off to volunteer in the community, plus the opportunity to work for a company that is pioneering a new glaucoma treatment class! Glaukos has been named one of the Top Workplaces by the Orange County Register for the past 3 years!
Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
