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Research and Developer Engineer

Cynet Systems
San Diego, CA Full Time
POSTED ON 4/26/2025
AVAILABLE BEFORE 5/15/2025

Job Description :

Pay Range : $72hr - $77hr

Responsibilities :

  • Conduct root cause analysis and implement corrective actions for product issues.
  • Support product design changes and ensure they meet regulatory and quality standards.
  • Decompose system requirements into subsystem or component specifications.
  • Develop and execute test documentation for verification and compliance testing.
  • Coordinate activities related to product changes with multiple cross-functional teams, including operations, quality, regulatory, and others.
  • Evaluate risks associated with product changes and provide mitigation strategies.
  • Provide input on reliability, verification, and validation testing.
  • Ensure compliance with ISO 13485, 14971, CFR21, CSA and other relevant regulations and standards.
  • Utilize statistical testing methods and design for manufacturing (DFM) and design for six sigma (DFSS) methodologies.
  • Collaborate with cross-functional teams to ensure successful product updates and solve complex problems under time sensitive deadlines.
  • Maintain thorough documentation of design changes, testing results, and risk assessments.
  • Interact with hardware suppliers to ensure design for manufacturability, testability and overall reliability.

Qualifications :

  • Bachelor's, Master's or PhD degree in Electrical Engineering or a related field.
  • Minimum 5 years of related experience.
  • Experience with Systems Engineering.
  • Track record of working successfully in a rapidly changing environment with high levels of uncertainty.
  • Strong understanding of ISO 13485, 14971, and other relevant standards.
  • Basic knowledge of PCB and PCBA design.
  • Experience with laboratory tools : oscilloscope, DMM, variable DC power supply, etc.
  • Experience with troubleshooting of electromechanical devices.
  • Basic knowledge of product safety and compliance design and testing.
  • Proven experience with structured problem solving, 8D, CAPA and other problem methodologies.
  • Knowledge of regulatory requirements for medical devices.
  • Experience with risk management and failure mode and effects analysis (FMEA).
  • Experience with statistical testing methods.
  • Excellent problem-solving skills and the ability to work in a fast-paced environment.
  • Strong communication and interpersonal skills to effectively collaborate with cross-functional teams.
  • bility to manage multiple projects and priorities simultaneously.
  • Proficiency in using engineering tools and software for design and analysis.
  • Preferred Qualifications :

  • Master's or PhD degree in Electrical Engineering or related discipline.
  • Experience with Alaris infusion products or similar medical devices.
  • Certification and experience in design for manufacturing (DFM), design for six sigma (DFSS) methodologies.
  • Critical components and critical parameters management experience.
  • Salary : $72 - $77

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