Job Description
Perform a variety of mechanical engineering activities on the ocular related products including product design, concept prototyping, concept testing, early development, clinical builds, manufacturing scale up development and sustaining activities. Responsibilities include developing creative solutions to design and manufacturing problems, ensuring the proper engineering deliverables are accurately generated, generation of 3D CAD models, 2D CAD drawings, test procedures, etc, project management/ leadership, maintaining schedule and product release plans. This individual will may lead project teams with other engineers, designers, and manufacturing staff with a focus on meeting product specifications with technically strong, high-quality, cost-effective designs following Glaukos's defined development process. Further, all duties shall be performed in a professional way with attention to detail while supporting Glaukos' Quality Policy and the appropriated regulatory agencies, including FDA Quality System Regulations (21 CFR 820), ISO Standards (EN ISO 13485) and Risk Management (EN ISO 14971).
Responsibilities
What You Will Do:
- Contribute to the development of new designs, manufacturing processes and other engineering & business procceses at all stages, from concept creation to product release
- Assists in or develops implantable Class III ophthalmic medical devices and the associated insertion system.
- Responsible for applying fundamental and advanced (depending on level) mechanical engineering principles, concepts, theories and techniques to solve complex problems related to product development / design and manufacturing while following company standard practices and procedures, and related specification.
- Responsible for generating proper engineering design models using SolidWorks 3-D parametric modeling software.
- Responsible for generating proper documentation including detailed 2-D part drawings, assembly drawings, engineering test protocols, engineering test reports, validation protocols, validation reports and other associated engineering documentation using, SolidWorks, MS Office Suite, etc. while ensuring proper engineering control guidelines are met and the appropriated level of detail is used.
- Assists in development of completed per project plan with defined milestones, which are defined by the project engineer, but approved by the team and management.
- Development work is completed to ensure safe and effective products that meet all worldwide quality, regulatory, marketing requirements. overall content upon completion. Individual must have the ability to lead projects and investigations with limited guidance.
- Other duties as assigned
Qualifications
- Bachelor's Degree BS Mechanical Engineering or equivalent Required
- Master's Degree MS Engineering or MBA Preferred
- 5+ years' work experience. Required
- 2+ years at E2 Required
- 2+ years of medical device experience Required
- Experience with ocular product Preferred
- Detail oriented with the ability to work in a clean room environment. Required
- Experience with phased new product development processes from concept through full production release. Required
- Ability to work in team environment as contributor and leader Required
- Ability to create and maintain scheduled plans while maintaining quality of engineering deliverables with guidance for engineering management. Required
- Excellent decision making/problem solving skills. Required
- Strong verbal and written communication skills. Required
- Proficient in MS Word, Excel, Outlook, and MS Power Point. Required
- Ability to use MS Project Required
- Knowledge of cGMP and ISO regulations Preferred
- Ability to fabricate assemblies under a microscope. Required
- Ability to interact with all departments Preferred
- SolidWorks capable, part, assembly and drawing generation. Required
- Appropriate years of experience working as an engineer on complex subassembly, top level assembly, fixtures, tooling and product builds. Required
- 2+ years of experience working with a wide range of manufacturing methods, including machined, extruded, molded and laser cut parts. Required
- Ability to interact with all departments . Required
- Ability to coordinate activities with outside vendors. Required
- Ability to author V&V and some DHF deliverables with guidance. Required
- Appropriate years of experience working as design and research engineer Required
- Strong knowledge of cGMP and ISO regulations Required
- Ability to author V&V and some DHF deliverables. Required
