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Staff Quality Engineer (Software) (Belmont)
Staff Quality Engineer (Software) (Belmont)HealthCare Recruiters International • Belmont, CA, US
Staff Quality Engineer (Software) (Belmont)

Staff Quality Engineer (Software) (Belmont)

HealthCare Recruiters International • Belmont, CA, US
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Client :

Our client is a well-funded start-up company that is building the future of medical robotics. Their next-generation robotic platform targets early diagnosis and treatment of patients across multiple disease states.

Job Location : (Hybrid) Open to San Jose or San Carlos locations

Responsibilites :

  • Provide hands-on guidance for establishing good product and system design requirements, design specifications, detailed designs, verification and validation activities, and planning documentation.
  • Understand clinical applications, workflow and user needs
  • Develop software-related verification and validation strategies for the R&D organization and ensure the execution of the strategies.
  • Serves as a technical resource for risk management activities for software in compliance with ISO 14971 and IEC 62304.
  • Develop test plans, and test cases based upon the product and component level requirements.
  • Partner with Human Factors SMEs and R&D to assess the usability of the software throughout design and development
  • Review and approve V&V system maintenance such as reworks and modification and tracking related to software upgrades.
  • Perform root cause analysis of identified design issues and identify appropriate corrective and preventive action. Use the NC and CAPA systems as needed to structure activities.
  • Perform audits of Design History Files and support both internal and external audits.
  • Support Regulatory Affairs with relevant submissions, approvals, requests, and inquiries.
  • Partner with PMO to apply project management tools in order to define project deliverables and establish a project schedule.
  • Work collaboratively and efficiently in a fast-paced environment with minimal supervision and guidance.
  • Maintain trained status for, and comply with all relevant aspects of Noah Medical Quality Management System to ensure product and support regulatory compliance.
  • As the voice of quality, this role will apply and promote best-practice use of statistical tools and techniques throughout the organization.
  • Other QMS activities not specified here and as assigned.

Requirements :

  • BS in Computer Science, Electrical Engineering, Biomedical Engineering, Mechanical Engineering, or other related programs.
  • Minimum of 8 years of Quality Engineering work experience in the medical device field with complex medical devices, i.e. devices that include capital hardware, disposable hardware, and software.
  • and a minimum of 3 years experience in a development QE function.
  • Experience in meeting Design Control and DHF requirements with NPD teams.
  • Well versed in the complete Quality Management System to meet US FDA and ISO / MDR requirements with an emphasis on IEC 62304.
  • Experience with Risk Management, FMEA, Hazard Analysis.
  • Experienced with statistical skills to define / train on test sample size and data analysis techniques.
  • Experienced in Microsoft Office, Google Suite, JIRA, Jama, and ePLM / eQMS systems.
  • Must be a self-starter, team builder, and excellent in verbal and written communication.
  • Preferred : Certifications : CQE, CQA(BM), CQM, 6 Sigma, etc.
  • Passionate about SW and technologies for healthcare

    • Workplace Type : Hybrid

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    Staff Software Engineer • Belmont, CA, US