12198BR

Title:

Process Development, Engineer I

Job Description:

Supports manufacturing process development with work including writing or verifying specifications, maintaining product process, designing fixtures, test processes, equipment and raw materials to ensure that subassemblies and finished products meet 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. • Support of new and existing manufacturing processes, new products, product changes and enhancements, as well as related tooling and fixtures • Drafts and executes validation of product, equipment and processes • Interfaces with other departments to solve production problems • Manages builds for new product development in prototype and pilot production setting, including training of operators and coordination with production planning • Analyze data and improve processes to assure robust/repeatable manufacturing processes • Manage process validation and product transfer activities across different manufacturing facilities • Review and develop manufacturing documents (MP, Routers, BOM, etc.) • Additional duties and responsibilities as assigned

Auto req ID:

12198BR

Location:

Aliso Viejo, California, USA

Department Name:

800-California Interventional Systems (CAIS)

Qualifications:

• Knowledge of Process Validations in medical device manufacturing environment

• Ability to read and prepare technical documentation

• Good problem solving and conflict management skills

• Working knowledge of standard machine shop equipment and processes

• Proficiency in SolidWorks and fixture/tooling design required

• Bachelor of Science in related field or equivalent experience

• 0 to 3 years of related experience

• Good communication skills

• Computer skills including Word, Excel and PowerPoint

External-Facing Title:

Engineer I, R&D Process Development

Posting Country:

US - United States

Salary Range:

$55,659 - $77,922 (compensation can be higher based on education, experience and skill set)

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, ethnicity, disability, religion, national origin, gender, gender identity, gender expression, marital status, sexual orientation, age, protected veteran status, or any other characteristic protected by law.