Careers That Change Lives A dynamic and experienced individual to join the Cranial and Spinal Technologies Operating Unit as aSoftware Quality Engineering Program Director. In this role you will be responsible for developing and leading implementation of quality management system processes for software as medical devices, ensuring compliance with regulatory standards, and driving innovation and consistency across a global operating unit's multiple design sites. The ideal candidate will have a strong background in software engineering, project management, and experience in quality/compliance/regulatory affairs within the medical device industry.This role will be responsible for processes that span across new product development programs and released product management activities of high complexity and varying risk classifications. Program results are accomplished through cross-functional resources who exercise significant latitude and independence in their assignments. A Day in the LifeDaily responsibilities, include but are not limited to: Provide strategic direction and leadership across quality and regulatory compliance processes for software products.Mentor and guide individuals and teams of software engineers, ensuring alignment with project goals and timelines.Understand and develop processes to manage the software development lifecycle* across a broad range of technology platforms, including medical device platforms, off-the-shelf platforms, and virtual networks.*[from initial concept to product launch, post-market support, and end-of-life]Ensure that all software programs comply with regulatory standards and guidelines, such as FDA regulations, ISO standards, and other relevant requirements. Work closely with Regulatory Affairs teams to facilitate the submission of regulatory documentation and approvals.Collaborate with cross-functional teams, including hardware engineering, design quality, reg affairs, and marketing to ensure seamless integration of software components into medical devices. Foster a culture of collaboration and communication to achieve project objectives.Develop processes and assist in identifying and mitigating risks associated with software development activities, including cybersecurity threats, software defects, and regulatory non-compliance. Implement robust risk management processes to safeguard the integrity and safety of medical devices.Drive continuous improvement initiatives to enhance the efficiency, quality, and reliability of software programs for medical devices. Stay abreast of industry trends, emerging technologies, and best practices to maintain a competitive edge in the market.Define appropriate measures to ensure product quality.May develop and/or implement key performance indicators and operating mechanisms for monitoring project progress, product performance, and intervention/problem solving.Influences across functions and businesses to negotiate and gain cooperation on operational issues and internal divergent objectives.Leads with high ethical standards. May lead a small unit of software engineering skillsets.Travel - <25%Must Have: Minimum RequirementsBachelors degree in a technically related field requiredMinimum of 10 years of relevant experience with 7+ years of managerial experience, or advanced degree with a minimum of 8 years of relevant experience with 7+ years of managerial experiencePreferred QualificationsMedical device experience in a quality or engineering function.Proven track record of successfully leading software development projects in the medical device industry.Strong understanding of regulatory requirements for medical device software, including FDA regulations (e.g., 21 CFR Part 820), ISO 13485, and IEC 62304.Excellent communication skills and the ability to effectively collaborate with cross-functional teams.Experience with Agile development methodologies and tools (e.g., Scrum, Kanban) is desirable.Strong analytical skills with the ability to define problems, collect data, establish facts, and draw valid conclusions.Ability to work cooperatively at all levels in matrix environment to build and maintain the positive relationships required to accomplish organizational goals. Effective decision-making skills - ability to negotiate and balance decisions and priorities across needs of several functional departments and global sites. Makes timely decisions in the face of risk and uncertainty.Certificate in software quality (e.g., ASQ CSQE) is a plus.Lean six sigma methodology / DFSS / DRM training recommended.About MedtronicTogether, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.Physical Job RequirementsThe physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.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.At Medtronic, most positions are posted on our career site for at least 3-7 daysLearn more about our benefits @ benefits.medtronic.comThis position is eligible for a short-term incentive plan. Learn more about Annual Salary and Medtronic Incentive Plan (MIP) on Page 6
