Engr 2, Mechanical

3 weeks ago


Brea, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Bachelor's degree in Mechanical Engineering, Biomedical Engineering or similar
  • Minimum of 3 years of post-educational professional experience
  • Fluent in CAD modeling using Solidworks or ProE
  • Graduate degree in Mechanical Engineering, Biomedical Engineering or similar
  • 5 years of post-educational experience in Medical Device Design
  • Experience with design best practices, including advanced tolerance design, design for reliability, and design for reusability.
  • Design for Six Sigma, Design for Manufacturability training / experience
  • Nice to have - Experience with injection molded plastics and design of high-volume disposables
  • Experience as mechanical lead in the development of high volume disposables
  • Proficiency with basic statistical techniques including familiarity with analysis of variance (ANOVA) and design of experiment (DOE) methodologies.
  • Expertise in common risk management techniques (FMEA, FTA, ETA).
  • Experience in modeling, simulations and sensitivity analyses.
  • Working knowledge of regulatory standards applicable to design of medical devices, including eu MDR, FDA QSR, ISO 13845, ISO 14971 and IEC 60601 and collateral standards
  • Lead Design control deliverable
  • bility to lead discussions cross-functionally
  • Self-directed and ability to learn
  • Perform/supervise testing
  • Create Design Verification plans/protocols
  • Perform/supervise testing
  • Hybrid flexibility 2-3 days a week
Requirements:
  • Excellent written & verbal communication skills
  • Minimal direction with the ability to learn and adapt quickly to new technologies and trends
  • Strong organization and coordination skills
  • Demonstrated customer focus, track record of innovation and publication
  • Must be comfortable making practical assumptions with engineering justifications, where needed.
  • bility to work independently.
  • bility to work under pressure and time constraints.
  • Effective interpersonal and collaborative skills.


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