Engineer II, Manufacturing process

Aliso Viejo, California, USA        ·       Full time

Job ID: 11065BR
Job Title: Engineer II, Manufacturing process
Location: Aliso Viejo, California, USA
320-Indirect Manufacturing

Job Description

Support manufacturing of products for medical devices with work including writing or verifying specifications; maintaining product processes; designing fixtures; and testing processes, equipment, and raw materials to ensure that the subassemblies and finished products meet their requirements.  Work closely with R&D, Quality, and Regulatory in supporting the development of new products and manufacturing processes to achieve a smooth, successful transfer to Manufacturing Engineering and Production for launch.

Job duties:

• Support of new and existing manufacturing processes, new products, product changes and enhancements, as well as related tooling and fixtures.
• Support validation of product, equipment, and processes.
• Interface with other departments to solve production problems.
• Monitor equipment maintenance program.
• Investigate and test product processes, NCR’s, DC’s and EO’s.
• Draft and execute validation of product, equipment, and processes.
• Manage builds for new product development in prototype and pilot production setting, including training of Assemblers and coordination with production planning.
• Analyze data and improve processes to assure robust/repeatable manufacturing processes.
• Confer with appropriate departments, resources, and/or outside services to prepare process modifications, clarify problems, and develop processes.
• Manage process validation and product transfer activities across different manufacturing facilities.
• Review and develop manufacturing documents (e.g., MP, Routers, BOM, etc.).
• Perform additional duties as assigned.

Qualifications

• Bachelor of science in related field or equivalent experience.
• Minimum of two (2) years of related experience.
• Strong written and verbal communication skills.
• Statistical Knowledge.
• Working knowledge of standard machine shop equipment and processes.
• Knowledge of medical and technical development.
• Proficient computer skills including MS Word, Excel, and Auto CAD.
• Knowledge of Process Validations in medical device manufacturing environment.
• Ability to read and prepare technical documentation.
• Good problem solving and conflict management skills.
• Proficiency in SolidWorks and fixture/tooling design.

Desired Qualifications

• Knowledge of statistical tools including Design of Experiments (DOE) and Cpk for process development characterization and optimization preferred.
• Green Belt or Black Belt certification.

Posting Country: Outside US

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