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.

A Day in the Life

A dynamic and experienced individual to join the Cranial and Spinal Technologies Operating Unit as a Software 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.

Daily 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 Requirements

• Bachelors degree in a technically related field required

• Minimum 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 experience

Preferred Qualifications

• Medical 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.

PROGRAM MANAGEMENT CAREER STREAM: Program Managers and Directors focus on tactical, operational activities for a major program with broad or ongoing impact. Levels within the program management career stream typically accomplish program objectives through matrixed employee teams and / or vendors who are not direct reports but for which the incumbent has direct accountability to lead. The majority of time is spent overseeing their area of responsibility, managing program/team performance, communicating project and operational developments, planning, prioritizing and / or directing the responsibilities of program team members. Goal achievement is typically accomplished through performance of program team members.

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. 

The 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. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

Benefits & Compensation

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.

Salary ranges for U.S (excl. PR) locations (USD):$187,200.00 - $280,800.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).This position is eligible for an annual long-term incentive plan.

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

Medtronic benefits and compensation plans (https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic)

About Medtronic

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 90,000+ 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 (http://www.medtronic.com) .

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

At Medtronic, most positions are posted on our career site for 3-7 days.

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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 90,000+ 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.

We change lives . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.

We build extraordinary solutions as one team . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.

This life-changing career is yours to engineer . By bringing your ambitious ideas, unique perspective and contributions, you will…

• Build a better future, amplifying your impact on the causes that matter to you and the world

• Grow a career reflective of your passion and abilities

• Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning

These commitments set our team apart from the rest:

Experiences that put people first . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.

Life-transforming technologies . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.

Better outcomes for our world . Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.

Insight-driven care . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) .

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