Manufacturing Engineer

Terumo Neuro
Aliso Viejo, CA

Engineer II, Manufacturing Process


Salary Range: $79,733 - $104,650

Financial compensation packages may be higher/lower than listed, & will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand


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.


What You'll be Doing

  • 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.).


Required Qualifications

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


What Will Differentiate You from the Crowd

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


Physical

  • Extended periods of computer use.
  • Extended periods of sitting or standing.
  • Extended periods of working in the clean room.
  • Moderate lifting, up to 50 lbs.
  • May be required within the position to be in an environment that can include radiation exposure (such as in Cathlabs).


EEO

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


Fair Chance Ordinance

If you are applying to perform work for Terumo Neuro in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Terumo Neuro reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.


Terumo Neuro will consider for employment qualified job applicants with arrest or conviction records in accordance with the California Fair Chance Act, Los Angeles County Fair Chance Ordinance for Employers, Fair Chance Initiative for Hiring Ordinance, and San Francisco Fair Chance Ordinance.

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