RESPONSIBILITIES:

• Lead, execute, and support on-time completion of Quality Engineering deliverables from product concept through commercialization, including but not limited to risk management activities (RMF, FMEA, Cybersecurity Risk Assessment)
• Support on-time execution of Quality Plans
• Guide development and documentation of standard operating procedures, specifications, and test procedures
• Support product recertifications
• CAPA management – including (but not limited to) performing thorough investigations with detailed root-cause analyses with established methods (Fishbone, 5 Why), implementing corrections, and corrective actions, and creating and monitoring effectiveness criteria.
• Work within the Agile software development lifecycle framework
• Support usability and human factors engineering reviews
• Coach and mentor team members on best practices in design quality, and overall product lifecycle testing/quality engineering to establish product and system reliability. Accent on agile testing and automated testing practices
• Participate in reviews for System and Software requirements, Software and Firmware design, and code inspection
• Review and approve test methods, protocols, and test results provided by another functional group.
• Support activities related to software change management and overall change management
• Bring forth ideas supporting continuous improvement and implement quality initiatives that measurably enhance medical device software and cybersecurity lifecycle activities
• Support all activities, as needed by the business within the software development lifecycle.
• Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
• Support internal & external audits and related responses
• Support the establishment of objective, measurable, and verifiable customer and product requirements
• Complete Document Change Request reviews in a timely and objective manner
• Additional duties may be identified by functional management based on the current project/business objectives.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintain positive, cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Perform other related duties and responsibilities, on occasion, as assigned.

EDUCATION AND EXPERIENCE:

• Bachelor-level degree in Computer science, biomedical engineering, software engineering or a closely related discipline or an equivalent combination of education and work experience.
• A minimum of 2-5+ years of combined experience in software design quality, cybersecurity design quality is REQUIRED
• Medical Devices experience in Software is REQUIRED
• Experience with ISO 14971 is REQUIRED
• FMEA experience is REQUIRED