Job Description

Noah Medical is seeking a highly motivated and solution-oriented Staff Design Assurance Quality Engineer- Software to join our Quality team. This role provides hands-on technical guidance and leadership from a Quality perspective throughout all stages of product development up to and including technology transfer and commercialization. The ideal candidate will be a self-starter, team builder, and excellent communicator, passionate about SW and technologies for healthcare.

Responsibilities

• Provide guidance for establishing product and system design requirements and specifications
• Review software verification and validation strategy and ensure compliance
• Serve as a technical resource for risk management activities for software
• Review test plans and test cases based on product and component level requirements
• Partner with Human Factors SMEs and R&D to assess software usability
• Review and approve V&V system maintenance related to software upgrades
• Review root cause analysis of design issues and identify corrective and preventive actions
• Perform audits of Design History Files and support internal and external audits
• Support Regulatory Affairs with relevant submissions, approvals, requests, and inquiries
• Partner with PMO to apply project management tools
• Apply and promote best-practice use of statistical tools and techniques
• Maintain trained status for and comply with all relevant aspects of Noah Medical Quality Management System

Requirements

• BS in Computer Science, Electrical Engineering, Biomedical Engineering, Mechanical Engineering, or related field
• Minimum of 8 years of Engineering work experience with a BS or 5 years with a PhD in the medical device or regulated industry
• Experience in meeting Design Control and DHF requirements with NPD teams
• Well versed in 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
• Must be a self-starter, team builder, and excellent in verbal and written communication
• Experience in a development QE function in a regulated environment is preferred
• Certifications: CQE, CQA(BM), CQM, 6 Sigma, etc. are preferred
• Experience with statistical skills to define/train on test sample size and data analysis techniques is preferred

Benefits

• No benefits