- Support new and existing manufacturing processes, new products, product changes and enhancements, as well as related tooling and fixtures.
- Review and develop manufacturing documents (MP, Routers, BOM, etc.).
- Draft and execute validation of product, equipment, and processes.
- Interface with other departments to solve production problems.
- Manage 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.
- 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.
- Investigate and test product processes, NCR's, DC, and EO's.
- Identify and execute on improvements, issues, or any process requirement with minimum supervision.
- Lead interdepartmental team on achieving goals.
- Perform additional responsibilities as assigned.
- Bachelor's degree in Mechanical Engineering, Industrial Engineering, or Material Science Engineering.
- Six (6) to eight (8) years of medical device industry experience.
- Statistical Knowledge (Green Belt or Black Belt).
- Strong written and verbal communication skills.
- Ability to effectively manage internal and external customer relationships as well as lead different key players on achieving a goal.
- Ability to design, execute, and analyze processes using designs/experiments. Ability to apply critical thinking and comprehensive technical translation in recommending process improvements.
- Ability to read and prepare technical documentation, including manufacturing and R&D procedures, specs, and engineering drawings.
- Expert proficiency with MS Word, Excel, PowerPoint, SolidWorks and/or other CAD systems.
- Experience with Guidewire and Balloon Catheters highly desirable.
- Ability to use and apply lean management principles to initiate, analyze, improve, and create engineering project and quality procurement systems.
- Experience working with manufacturing process development projects and transfer of R&D projects into high volume production.
- Ability to prioritize and meet deadlines in a timely manner.
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Staff Engineer, R&D - Aliso Viejo, United States - MicroVention
Description
12159BR
Title:
Staff Engineer, R&D
Job Description:
Support manufacturing of products for medical devices with work including writing or verifying specifications; maintaining product process; designing fixtures; and testing processes, equipment, and raw materials to ensure that the subassemblies and finished products meet requirements. Work closely with R&D counterparts, 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 and continue leading product sustaining. Job duties:
Auto req ID:
12159BR
Location:
Aliso Viejo, California, USA
Department Name:
642-R&D Admin-Access
Qualifications:
Desired Qualifications
External-Facing Title:
Staff Engineer, R&D
Posting Country:
US - United States
Salary Range:
$99,266 - $138,972 (Compensation can vary based on education, experience and skill sets)
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.
