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Southern California

  • Staff R&D Engineer – Phase II Product Design

    Irvine, CA

    Primary Job Function:
    Responsible for providing engineering support and leading team in the creation and development of new medical device products to meet customer and market demands in the rapidly growing

    Core Job Responsibilities:
    1. Lead and execute development activities through a phase gate development process.
    2. Drive and derive solutions to all design challenges and specifications development.
    3. Supervise engineers, technicians, assemblers and/or contract professionals as needed throughout project phases. Coach and motivate team to accomplish project goals.
    4. Identify suitable processing and material technologies, develop solutions with vendors to fit a
    demanding project timeline. Complete vendor qualification to deliver technologies that are cost
    efficient meeting quality targets and all phase goals.
    5. Manage project schedules and reports to management team.
    6. Lead and coach team to generate all DHF, DMR deliverables while working in a QMS design control environment to complete design.
    7. Plan and lead physician meetings to obtain accurate and efficient feedback on developing concepts and prototypes.
    8. Coordinate and assemble efficient protocols, test plans and reports on technical due diligences.
    9. Develop and validate test methods.
    10. Develop and validate manufacturing processes to meet LEAN, output and quality targets.
    11. Scale up and transfer manufacturing processes to high volume production sites OUS to meet cost, output, quality and launch targets.
    12. Support product commercialization and indication expansion initiatives in partnership with the broader cross-functional team.
    13. Generate IPs.
    14. Serves as a technical advisor on technical acquisitions and new technology development teams.

    Supervision Received:
    The Sr. Staff engineer should work with cross functional team and management to execute plans to fulfill project and organizational goals. Works is performed without day-to-day direction. Exercises considerable latitude in determining technical objectives of assignment. Completed work is reviewed from a relatively long-term perspective for desired results.

    Supervision to Provide:
    May provide work direction and guidance to exempt and/or skilled nonexempt levels of employees, maybe asked to evaluate performance of and assist in career development planning for subordinates.

    Minimum Education:
    Bachelors of science degree (BS) in relevant engineering field plus 12+ years of related work experience with complete understanding of specified functional area or an equivalent combination of education and work experience. Advanced degree preferred.

    Experience/Training Required:
    1. Hands-on medical device experience in heart valves, stents, catheters, delivery system, balloon catheters, and/or interventional access devices is preferred.
    2. Have delivered projects through all development phases with final launch success.
    3. Practical knowledge on most common thermoplastics, metals, plastic molding, welding, laser
    cutting, extrusion and catheter assembly technologies.
    4. Ability to juggle multiple priorities and projects to meet demanding timelines.
    5. Ability to work well both independently and as a member of a team is essential.
    6. Understanding of statistical techniques is required.
    7. CAD experience using Solidworks is essential.
    8. Effective communication skills are required.
    9. Strong analytical, problem solving and technical writing skills are preferred.
    10. Experience with best practices: DFM, Agile, FMEA, LEAN and Six Sigma, etc.

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