Job Description

Noah Medical is seeking a highly motivated and solution-oriented Sr. Design Quality Engineer to provide 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, with a strong background in medical device or similarly regulated industry.

Responsibilities

• Provide guidance for establishing product and system design requirements, design specifications, detailed designs, verification and validation activities, and planning documentation
• Review hardware and system-related verification and validation strategy for the R&D organization and ensure the execution of the strategy
• Participate in development activities, including design reviews, requirements analysis and tracing, and configuration management
• Serve as a technical resource for risk management activities for hardware and systems in compliance with ISO 14971 and IEC 60601
• Review test plans, and test cases based upon the product and component level requirements ensuring that appropriate statistical techniques are applied
• Review and approve V&V system maintenance such as reworks and modification and tracking
• Partner with cross-functional teams to collaborate on root cause analysis of identified design issues and identify appropriate corrective and preventive action
• Support field service engineering requests and assess serviceability risks
• Partner with PMO to apply project management tools in order to define project deliverables and establish a project schedule
• Foster a culture of quality throughout the organization by sharing best practices and promoting quality awareness
• Participate in clinical labs, formative and summative human factors studies to ensure product safety, usability, and regulatory compliance

Requirements

• BS in Engineering or Technology, Mechanical, Industrial, Electrical, Life Sciences, etc.
• Minimum of 4 years of Engineering work experience with a BS in the medical device or similarly regulated industry or minimum of 2 years of Engineering work experience with a PhD
• Preferred 2 years experience in a development QE function in a regulated environment
• Experience in meeting Design Control and DHF requirements with R&D teams
• Experience with Quality Management System to meet US FDA and ISO/MDR requirements
• Experience with Risk Management, FMEA, Hazard Analysis, GD & T requirements
• Experienced with statistical skills to define/train on test sample size and data analysis techniques
• Use Design For Manufacturability, Assembly and Service-ability principles to reduce the cost, simplify assembly and serviceability
• Experienced in Microsoft Office, Google Suite, Jama, and ePLM/eQMS systems
• Must be a self-starter, team builder, and excellent in verbal and written communication
• Certifications: CQE, CQA(BM), CQM, 6 Sigma, etc. (Preferred)

Benefits

• No benefits