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Project Engineer

Company: Diverse Lynx
Location: Irvine
Posted on: November 26, 2022

Job Description:

Job Title
Project Engineer
Irvine, California

Relevant Experience
(in Yrs)
Bachelors degree in engineering or science (Biomedical, Mechanical, Electrical, Biology, etc)
3+ years of medical device industry experience in design control and/or project engineering

Technical/Functional Skills

  • Ability to quickly build connections with internal and external partners
  • Ability to manage multiple projects and tasks simultaneously
  • Ability to read engineering drawings, GD&T, terminology, schematics
  • Knowledge and experience in product development processes and design control is preferred.
  • In-depth knowledge of design of medical devices preferred.
  • Ability to be a technical leader on multi-functional teams
  • Excellent verbal and written communication skills, including but not limited to, the ability to relate technical requirements, listen effectively, influence decision-makers by data and be able to receive constructive input from others.
  • Ability to solve complex problems

    Experience Required
    5-6 Years

    Roles & Responsibilities
    Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate, procedures and guidelines, the duties and responsibilities for this position are:

    • Responsible for the successful planning, coordination, execution, implementation, and timely completion of project deliverables ensuring consistency with company policies, procedures, and commitments
    • Lead and drive execution of design for manufacturing including component manufacturing within the principles of DMAIC
    • Ensure on-schedule and on-cost delivery of projects while managing project activities during all phases such as Engineering, Documentation, Process, Operations, Planning, etc.
    • Communicate with all project stakeholders, core team, extended team, and cross-functional members
    • Develop innovative workflows to generate compelling technical evidence of product or project performance under challenging conditions
    • Prepare and present technical information in a clear and effective manner to project leads, managers, stakeholders
    • Review and coordinate drawings, BOMs, specifications, protocols, test reports, plans, etc.
    • Actively coordinate and mitigate delays within project and tasks
    • Collaborate with cross-functional team, work with engineering, manufacturing, marketing and suppliers
    • Ensure continued compliance of project and/or portfolio to applicable standards and regulations
    • Create, track, and maintain all project documentation and progress such as Design History File, Design History Records, Engineering Change Orders, Technical File, etc.
    • Follow strict adherence to policies and procedures associated with FDA and any other Notified Body (EU-MDR, PMDA, NMPA, ANVISA, etc) controlled environment

      Generic Managerial Skills
      Project Management experience

      A minimum of bachelors degree in Electrical, Mechanical or Biomedical Engineering or masters degree in Electrical, Mechanical or Biomedical Engineering.

      Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.

Keywords: Diverse Lynx, Irvine , Project Engineer, Engineering , Irvine, California

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