Senior Research and Development Engineer

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Company: Cynet Systems

Location: Irvine, CA 92620

Description:

Job Description:

Pay Range: $51.82hr - $56.82hr

Responsibilities:
  • 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.
  • 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.
  • ssign 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.
Required Qualifications:
  • Bachelor's degree in Engineering with a minimum of 4 years of experience in either NPD, Quality Engineering, R&D, and/or Manufacturing.
  • master's degree in engineering or Scientific field with internship, senior projects, or thesis experience required.
  • Engineering experience within a highly regulated industry.
Preferred Qualifications:
  • Experience in medical device (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 Excel, Power Point, and Word Project.
  • Experience with using Adobe Acrobat.
  • Basic understanding of statistical techniques.
  • Strong problem-solving, organizational, analytical, and critical thinking skills.
  • Self-project management and tracking of deliverables with various participants and stakeholders.
  • Strong communication skills across various cross-functional groups and levels.

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