What You'll Do:
Performs a variety of manufacturing engineering activities on ocular related products including manufacturing scale up, development, and sustaining activities. Responsibilities include developing creative solutions to manufacturing problems, development and execution of process, equipment, and product validations, ensuring the proper engineering deliverables are accurately generated, generation of 3D CAD models and 2D CAD drawings for assembly tools and fixtures, test procedures, project management and leadership, and maintaining schedule. May lead manufacturing related project teams with other engineers, technicians, and manufacturing staff with a focus on meeting manufacturing requirements with technically strong, high quality, cost effective approaches. 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).
Develop and Improve Manufacturing Methods and Processes
- 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.
- Write process protocols, reports, manufacturing instructions, procedures, and FMEA.
- 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.
- Determine specific requirements of manufacturing operation in order to specify equipment, fixturing, and process parameters. Collaborate on design with suppliers to fulfill equipment and fixturing requirements. Establish and manage preventive maintenance program.
- 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.
How You’ll Get There:
Experience:
- BS Mechanical Engineering or equivalent required
- 2+ years of medical device or pharmaceutical experience.
- 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
- Ability to create and maintain scheduled plans while maintaining quality of engineering deliverables with guidance for engineering management.
- Excellent decision making/problem solving skills.
- Strong verbal and written communication skills.
- Proficient in MS Word, Excel, Statistical Software, Outlook, and MS Power Point.
- Ability to use MS Project (Only for level Sr and Principal).
- 2+ years or experience working as manufacturing engineering on complex medical device / pharma subassembly and top-level assembly builds.
- 2+ years of experience working with a wide range of manufacturing methods, including machined, extruded, molded and laser cut parts.
- 2+ years’ experience generating tooling / fixturing design to support production, Solidworks design preferred.
- Knowledge of cGMP and ISO regulations required.
- Experience with MRP a plus.
- Ability to interact with all departments required.
- Ability to coordinate activities with outside vendors.
