Staff Manufacturing Engineer NPD
Location: California City
Posted on: September 20, 2022
Staff level engineer responsible for the design and development of
manufacturing processes, tooling, and fixtures in support of a next
generation AAA and Peripheral devices. Support operations personel
with sustaining products and collaborate with the R&D
organization to help facilitate the successful execution of the New
Product Development Process and launchingand supporting of robust
- Support operations in the daily output of existing products and
- Design and develop manufacturing processes for new AAA and
- Design and develop fixtures and tooling for new AAA and
- Leader of the manufacturing development process with direct
input into timelines and critical path items
- Work with R&D staff to ensure that design for
manufacturability principles are applied to new processes.
- Plan, schedule, and complete projects in a manner consistent
with business objectives.
- Operations liaison for the project team responsible for
communications to all appropriate operations groups.
- Develop and execute process validation protocols
- Analyze process data and make decisions/recommendations
relating to process capability and DFM.
- Support prototype and pilot production of new products, product
changes, and enhancements in coordination with the Manufacturing
and Quality Control functions.
- Investigate benefits and features of capital equipment and
generate capital appropriation justifications.
- Create and maintain accurate documentation of concepts, designs
concepts, tool drawings and shop orders in coordination with the
Quality Assurance and R&D functions.
- Contact and address component and/or raw material issues with
- Contribute to the intellectual property position of the company
via invention and patent applications.
- Maintain current knowledge of medical, technical, and
biomedical developments as related to company products.
- Maintain GMP compliance relating to Document Control, R&D,
and Quality Assurance.
- Support company goals and objectives, policies and procedures,
and FDA regulations.
- Ensure that all regulatory and internal policies are
- Assist engineering manager in development of engineers
providing assistance with coaching and mentoring.
- Identifies hazards and mitigates risk associated with
identified hazards in Process FMEA.
- Perform other duties as assigned by supervisor.
- Requires a Bachelor of Science degree in Engineering or related
technical degree (i.e. physics or mathematics)
- Requires a minimum of 8-10 years related experience.
- Experience with catheters and interventional delivery systems
- Knowledge in the following areas of manufacturing highly
recommended, Balloon catheters, stent forming, PTFE, delivery
systems, aseptic processing, pressure monitoring devices and
injection mold design.
Keywords: Endologix, Lancaster , Staff Manufacturing Engineer NPD, Engineering , California City, California
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