Glaukos Corporation
Manufacturing Engineer II
San Clemente, CA, United States · Mid
Sponsorship not specifiedDetected 136 days ago
Project ManagementExcelProcess ImprovementERPSolidWorksMechanical DesignGMPFDA RegulatoryMedical DevicesLeadershipCommunicationProblem SolvingMicrosoft Office
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Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70
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About the role
- Duties shall be performed with attention to detail while supporting Glaukos' Quality Policy and the appropriate regulatory agencies, including FDA Quality System Regulations (21 CFR 820), 21 CFR 210/211 and ISO Standards (ISO 13485).
- Applies six sigma methodology as appropriate.
Responsibilities
- Develop and improve manufacturing methods, systems, and processes to produce high quality products that are complex and broad in scope at optimal cost.
- Support new product development or existing product line extensions/modifications by ensuring new products or manufacturing processes are designed to facilitate ease of manufacturing and to produce quality, cost effective products with optimized yields.
- Provide manufacturing input during design review meetings.
- Provide engineering support to the manufacturing operation on routine basis. Address product and process related issues arising on the production floor including proactively identifying and solving known issues to improve yields and cost.
- Identify and evaluate opportunities for improvement and make specific recommendations for adoption. Perform cost analyses to reduce or optimize product costs.
- Ensures compliance with GMP's and internal protocol. Uses appropriate statistical support and Design of Experiments (DOE) when developing recommendations.
- Utilize establish ERP system to support manufacturing operations.
- Design and/or provide oversight for processes, fixtures, and tooling for associated manufacturing operations.
- Develop plans to evaluate process repeatability and stability through equipment qualification and process validation. Applies six sigma methodology as appropriate.
- Performs a variety of manufacturing engineering activities on ocular related products including manufacturing scale up, development, and sustaining activities.
Nice to have
- BS Mechanical Engineering or equivalent required
- Experience with ocular product a plus
- Detail oriented with the ability to work in a clean room environment.
- Experience with phased new product development processes from concept through full production release.
- Ability to work in team environment as contributor and leader
- Excellent decision making/problem solving skills.
- Strong verbal and written communication skills.
- Proficient in MS Word, Excel, Statistical Software, Outlook, and MS Power Point.
Benefits
- 2+ years of medical device or pharmaceutical experience.
- 2+ years or experience working as manufacturing engineering on complex medical device / pharma subassembly and top-level assembly builds.
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This listing is sourced directly from Glaukos Corporation's careers page and normalized into a canonical job model.