Senior Manager, SW Quality

Job Opportunity:

The Senior Manager focusing on Software Quality and associated design controls will have the opportunity to develop and improve technology platforms that improve the lives of those suffering from Heart Failure.

The Senior Manager, Software Design Control, is responsible for managing a team of software quality engineers who partner with the Software Development Groups and other functions to solve problems and make sound design recommendations, in accordance with Company and regulatory requirements/guidance, and standards. This position provides leadership and mentoring to software quality engineers and must perform as a hands-on contributor, as necessary.

Job Responsibilities:

• Provide guidance and strategic input to teams for development of medical product software (Cloud-Based Patient Care Networks, Mobile, and Embedded software), non-medical software, and non-product software.
• Lead improvement of the Heart Failure Division’s software design controls to meet the needs of evolving technology and regulatory landscape around mobile software platforms and embedded software.
• Partner with the Product Security Group to continually improve cybersecurity and associated quality system processes
• Provide quality assurance oversight for software development lifecycle (SDLC) deliverables such as requirements, risk management, tracing, software V&V, regression, defect management, etc.
• Hire and retain a diverse, highly qualified staff and provide ongoing performance feedback.
• Set goals which align to business and department plans and manage the execution of goals through coaching and mentoring.
• Assess resource needs to ensure that an appropriate level of quality support is provided with the competencies needed.
• Develop direct reports by securing appropriate training, assigning progressively challenging tasks, and providing regular written and verbal performance feedback.
• Ensure that appropriate risk management processes are in place, focused on software-related risks including design, cybersecurity, and data integrity risks.
• Lead, oversee, or participate in multiple portions of the Quality System, including but not limited to Management Review, Internal Audit, Audit Readiness, CAPA, Document Control, Training, Product Release, and others as needed.
• Be an effective member of the cross-departmental Functional Management Team to foster continuous quality, compliance, cost, and efficiency improvements.
• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and suppliers.
• Ensure sustaining support of Quality System and regulatory compliance by individually working quality system issues and by delegating project work for maintaining quality system capability.

Required Qualifications:

• Bachelor’s degree, preferably in Engineering, Computer Science, Life Science, or closely related discipline.
• 9+ years of experience in a Quality, Regulatory, or product development role in the medical device industry.
• 5+ years of experience managing a team of technical/quality professionals.
• Knowledge of FDA regulations and guidance, ISO 13485, Software Standards (e.g., IEC 62304), EU Medical Device Regulations, and MDSAP

Preferred Qualifications:

• Direct experience with SDLC for Cloud-based medical device networks and mobile medical device applications