Noah Medical is looking to solve the business problem of developing the future of medical robotics, specifically targeting early diagnosis and treatment of patients across multiple indications, by hiring a Staff Design Assurance Quality Engineer- Software to provide hands-on technical guidance and leadership from a Quality perspective.
Requirements
- BS in Computer Science, Electrical Engineering, Biomedical Engineering, Mechanical Engineering, or other related programs.
- Minimum of 8 years of Engineering work experience with a BS or a minimum of 5 years of Engineering work experience with a PhD in the medical device or similarly regulated industry.
- Preferred: minimum of 3 years experience in a development QE function in a regulated environment
- 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 requirements with an emphasis on IEC 62304.
- Experience with Risk Management, FMEA, Hazard Analysis.
- Experienced in Microsoft Office, Google Suite, JIRA, Jama, and ePLM/eQMS systems.
Responsibilities
- 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
- Review software related verification and validation strategy for the R&D organization and ensure compliance to the execution of the strategy.
- Serves as a technical resource for risk management activities for software in compliance with ISO 14971 and IEC 62304.
- Review 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.
Other
- Must be a self-starter, team builder, and excellent in verbal and written communication.
- BS in Computer Science, Electrical Engineering, Biomedical Engineering, Mechanical Engineering, or other related programs.
- Minimum of 8 years of Engineering work experience with a BS or a minimum of 5 years of Engineering work experience with a PhD in the medical device or similarly regulated industry.
- Preferred: Certifications: CQE, CQA(BM), CQM, 6 Sigma, etc.
- Passionate about SW and technologies for healthcare
