Research and Development Engineer II

2 days ago


Irvine, United States JobRialto Full time
Job Summary:


  • This Engineer II will
    apply knowledge of quality engineering principles and methods to ensure
    compliance with regulatory requirements and systems/procedures to optimize
    product design, internal and external device manufacturing, and device
    distribution. Furthermore, this Quality Engineer will coordinate and
    perform complaint investigations as well as DMR/DHR changes in support of
    clinical inventory.


How you will make an impact:


  • Support areas of Quality
    Assurance, Design Controls, Risk Management, Manufacturing Controls, and
    Statistical Techniques for New Product Development (NPD) programs
  • Investigate complex
    manufacturing product quality and compliance issues reported from the
    field, analyze results, determine root cause/probable cause, and initiate
    and review reports.
  • Coordinate and execute
    change control activities to support rapid innovation
  • Support design and
    development activities (i.e., engineering study, feasibility testing,
    drawing review, etc.)
  • Participate in
    escalation tasks and activities, including Project Risk Assessments (PRA)
  • Supports or leads test
    method development/validation activities for Design Verification testing
    and manufacturing inspections for NPD programs
  • Collaborate with R&D
    and Manufacturing organizations to facilitate the successful execution of
    the NPD process and launching of robust products
  • Develop complex
    experiments and tests (including writing and executing protocols) to
    create, improve, and validate products and manufacturing processes by
    analyzing results, making recommendations, and developing reports
  • Develop, update, and
    maintain technical content of risk management files
  • Develop training and
    documentation materials (e.g., work instructions) for production to enable
    the seamless knowledge transfer of project and manufacturing processes
  • Assign and oversee
    manufacturing support tasks; give instruction to technicians on conducting
    tests; train technicians and provide feedback; and coordinate technician
    work
  • Other incidental duties
    assigned by Leadership
  • Ability to travel up to
    10% domestically and internationally


What you'll need (Required Qualifications):


  • Bachelor's degree in
    Engineering or Scientific field with a minimum of (2) years of experience
    in either NPD, Quality Engineering, R&D, and/or Manufacturing; OR a
    Master's degree in Engineering or Scientific field with internship, senior
    projects, or thesis experience required.
  • Engineering experience
    within a highly regulated industry


What else we look for (Preferred Qualifications):


  • Experience in medical
    devices (cardiovascular, endovascular, or other critical care/surgical
    products), healthcare, or a related environment preferred.
  • Knowledge and experience
    within Design Assurance, including Design Controls, Design Verification
    & Validation, Test Method Development, and Process Validation
  • Experience with root
    cause analysis or investigations for Complaints, NCRs, and/or CAPAs.
  • New Product Development
    experience from initial concept to commercialization (Class III
    preferred).
  • Experience with Risk
    Management and Design Control
  • Proven expertise in
    usage of MS Office Suite including MS Project
  • Basic understanding of
    statistical techniques
  • Strong problem-solving,
    organizational, analytical, and critical thinking skills


Education/Experience:


  • Bachelor's degree in
    engineering required.
  • 2-4 years experience
    required.


Education: Bachelors Degree

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