Software Quality Engineering Manager

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

Responsibilities may include the following and other duties may be assigned.

• Plans, directs and implements all aspects of the company's design and development of new medical device products or software systems.
• May develop, evaluate, implement and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products.
• Oversees the investigation and evaluation of existing technologies.
• Guides the conceptualization of new methodologies, materials, machines, processes or products.
• Coordinates Medical Device Product development and SDLC (Software Development Life Cycle), including complex government and industry regulations, including FDA 21 CFR Part 11 and Part 820, ISO 13485, ISO 14971, Supplier quality & PSURs & IEC 62304; understand and work with various programming languages such as C, C++, C#, and Python. Directs the development of new concepts from initial design to market release.
• Manages feasibility studies of the design to determine if capable of functioning as intended.
• Monitors software documentation maintenance throughout all phases of research and development.
• Organizes the coordination of activities with outside suppliers and consultants to ensure timely delivery.
• Define and implement software quality metrics to track software progress and quality throughout the development process, implement software risk and reliability tools, including Software Failure Mode and Effects Analysis (SFMEA) and Software Fault Tree Analysis (SFTA), and practices that effectively support software requirements for the product software, design, integration, verification, validation, and prediction.
• Coordinate numerous Software validation processes, Software Cybersecurity, Medical Device Design Controls, Design History File, and Product Life Cycle; and understand process of software validation, Test Methods Development, Automation testing, Verification, and Validation of product software.
• Liaison between the R&D software development and software test engineering teams to ensure compliance to the standards and internal procedures
• Directs the development of new concepts from initial design to market release.
• Manages feasibility studies of the design to determine if capable of functioning as intended.
• PEOPLE MANAGEMENT FUNCTIONAL CAREER STREAM: 
• Management and supervisory professionals with one or more employees who are focused on tactical, operational and some strategic activities within a specified area. Levels within the management career stream typically have six or more direct reports.
• The majority of time is spent overseeing their area of responsibility, managing performance, developing talent, engagement and inclusion, communicating business and operational developments, planning, prioritizing and / or directing the responsibilities of direct reports. Goal achievement is typically accomplished through performance of direct and / or indirect reports.
• A key responsibility of roles in this career stream is managing people. which includes: accountability for mentoring, developing and coaching staff on meeting/exceeding performance expectations and defined objectives, providing leadership to staff ensuring the prioritization of strategic and department level initiatives to include defining performance goals and targets, conducting performance reviews, and staff 1:1s to guide performance management and employee development efforts and manage toward departmental goals.
• DIFFERENTIATING FACTORS are mentioned in below
• Autonomy: Manages subordinate supervisors and/or experienced professionals who exercise latitude and independence in assignments.
• Provides tactical and / or operational leadership and coaching.
• Receives assignments in task and objective oriented terms.
• Organizational Impact: Establishes operational plans and implements policies and strategies.
• Decisions impact program schedules, customer satisfaction levels, or allocation of time, material resources, expenditures and funds.
• May have budget or P&L accountability for a department, function or geography.
• Strive for continuous improvement and consistency in deliverables.
• Innovation and Complexity: Proposes modifications to functional operating policies and day-to-day processes.
• Problems and issues faced are complex, difficult and undefined, and require detailed information gathering, analysis and investigation to understand the problem.
• Communication and Influence: Communicates with internal and external customers and vendors regarding ongoing operations.
• Uses information exchange, influence and active persuasion without direct exercise of command to gain cooperation of other parties .
• May interact on issues that have externally shared objectives.
• Leadership and Talent Management: Manages a team consisting of supervisors and / or experienced professionals in the Specialist career stream.
• Leads, directs and reviews the work of a team who exercise latitude and independence in their assignments.
• Authorizes hiring, firing, promotion and reward within own area.

Required Knowledge and Experience: 

• Requires practical knowledge in leading and managing the execution of processes, projects and tactics within one job area.
• Medical Device Product development, SDLC (Software Development Life Cycle), FDA 21 CFR Part 11, ISO 13485, ISO 14971 and IEC 62304.
• Software Cybersecurity, Medical Device Design Controls, Design History File, and Product Life Cycle
• Software risk assessment using tools like SFMEA and SFTA
• Master’s degree in Computer Science or Software Engineering and five (5) years of experience in Software Quality Engineering or Software Engineering.

Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
 

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. 
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here