Excellent opportunity with growth potential for an experienced Manufacturing Engineer within Medical Device!
Summary of Position with General Responsibilities:
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.
- 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.
- Proficient using Solidworks.
- Other duties as assigned.
- Bachelor's degree in an engineering discipline, preferably mechanical or electrical.
- 10+ 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.
- PFMEA/Risk analysis.
- Fixture design experience (Mechanical, Electrical, Optical)
- Proficiency using Solidworks Composer
- Excellent verbal and written communication skills.
- Experience with optics design and fixturing
- 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
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.