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R&D Mechanical Engineer I

Ledgent Technology Milpitas Full-Time
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We are seeking to add an R&D Mechanical Engineer to our team. 
Candidate must be authorized to work in the US and local to the San Francisco Bay Area.


ESSENTIAL FUNCTION:
  1. Develop mechanical and electromechanical medical systems that include a disposable device, primarily made from plastic, and may interface to an electronic instrument. 
  2. Create and/or translate component/subassembly/product requirements into measurable specifications.
  3. Determine sub-system and component design and performance requirements.
  4. Design or source required sub-systems and components and help integrate then into the final product.
  5. Assist with product/component design verification and system validation.
  6. Assist with development activities required for product marketing including packaging and labeling, materials selection and biocompatibility testing, etc.
  7. Write technical reports to support regulatory agency approval(s) (e.g. US FDA).
  8. Assist with creation of Device Master Records, including specifications, manufacturing procedures, quality instructions, and test procedures.
  9. Assist with transfer into manufacturing, including equipment, tooling and fixture development, process development and process validation.
  10. Assist with training of manufacturing and quality engineers, assemblers, technicians and other support personnel.
  11. Create and/or augment documentation in the Design History File.
  12. Maintain records of ideas, developments and test results in a bound notebook.
  13. Assist with preparation of documentation to support proprietary information development.

EDUCATION AND EXPERIENCE:

Typically requires a BS degree in Mechanical Engineering. At least 2 years of Mechanical Engineering experience. 
Familiarity with plastics and their fabrication processes (e.g. extrusion, injection molding, machining {lathe turning and milling}, adhesive bonding, etc.).
Experience using Solid Works or other solid modeling software, and general machine shop experience (e.g. lathe, mill, hand tools, etc.).
Medical Device experience is highly desired.

 

We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
ESSENTIAL FUNCTION: 1. Develop mechanical and electromechanical medical systems that include a disposable device, primarily made from plastic, and may interface to an electronic instrument. 2. Create and/or translate component/subassembly/product requirements into measurable specifications. 3. Determine sub-system and component design and performance requirements. 4. Design or source required sub-systems and components and help integrate then into the final product. 5. Assist with product/component design verification and system validation. 6. Assist with development activities required for product marketing including packaging and labeling, materials selection and biocompatibility testing, etc. 7. Write technical reports to support regulatory agency approval(s) (e.g. US FDA). 8. Assist with creation of Device Master Records, including specifications, manufacturing procedures, quality instructions, and test procedures. 9. Assist with transfer into manufacturing, including equipment, tooling and fixture development, process development and process validation. 10. Assist with training of manufacturing and quality engineers, assemblers, technicians and other support personnel. 11. Create and/or augment documentation in the Design History File. 12. Maintain records of ideas, developments and test results in a bound notebook. 13. Assist with preparation of documentation to support proprietary information development. REQUIREMENTS: At least 2 years of Mechanical Engineering experience. Familiarity with plastics and their fabrication processes (e.g. extrusion, injection molding, machining {lathe turning and milling}, adhesive bonding, etc.). Experience using Solid Works or other solid modeling software, and general machine shop experience (e.g. lathe, mill, hand tools, etc.). Medical Device experience is highly desired.

Skills required

Structural Engineering
Engineer In Training
Staad
Civil Engineering
Engineering Design Process
Autocad
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Job ID: JO-1906-63063

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