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 LifeJoin a forward-thinking team of software engineers and strategists responsible for the development and execution of the AIBLE Program, which aims to integrate advanced software solutions with strategic business
initiatives while adhering to FDA regulations and safety standards.
Responsibilities may include following other duties may assigned
- Plan, direct, and implement all aspects of the AIBLE Program, including the design and development of new software systems that align with business strategies and FDA regulations.
- Collaborate with business leaders to identify opportunities where compliant software solutions can drive business value and improve strategic outcomes.
- Develop, evaluate, implement, and maintain technical quality assurance, risk management, and control systems specific to software development, ensuring compliance with FDA standards (e.g., ISO 14971, IEC 62304).
- Oversee the investigation and integration of emerging technologies, ensuring they meet both innovation and regulatory requirements.
- Guide the conceptualization and development of new software methodologies, tools, and processes that enhance business performance while adhering to safety and regulatory standards.
- Direct the development of software solutions from initial concept through to market release, ensuring alignment with business goals and regulatory compliance.
- Manage feasibility studies to evaluate the potential business impact, technical viability, and regulatory compliance of new software initiatives.
- Ensure documentation, risk management, and compliance throughout all phases of software development, adhering to FDA and industry standards.
- Coordinate with external vendors and consultants to ensure the timely delivery of software components that meet both business and regulatory requirements.
- Select, develop, and evaluate team members to ensure the effective execution of program objectives within a compliant framework.
Required knowledge and Experience
- 14+ years of overall experience in IT with 6 years of relevant project management experience, particularly in software-centric and regulated programs.
- Bachelor’s degree in Engineering, Computer Science, Business, or a related discipline with a strong emphasis on software and business strategy.
- Experience in managing teams with a strong focus on software development, business strategy, and regulatory compliance: Accountability for mentoring, developing, and coaching staff to meet or exceed performance expectations, strategic objectives, and regulatory requirements. Provide leadership to ensure the prioritization of strategic, departmental, and compliance initiatives, including defining performance goals, conducting performance reviews, and guiding staff development.
- Exceptional influencing and interpersonal skills, with proficiency in negotiation, change management, goal setting, and conflict resolution, particularly in a software-driven and regulated environment.
- Experience with AI/ML, data analytics, and their application in business strategy, within a compliant framework.
- Familiarity with FDA regulations, ISO 14971 (Risk Management), IEC 62304 (Software Lifecycle Processes), and other relevant standards.
- Lean/Six Sigma certification is a plus, with an emphasis on process improvement in regulated software development.
- Manage one or more medium-scale, software-centric programs with well-defined program plans, delivery methodologies, and compliance strategies. Accountable for overall program processes, performance, and alignment with business strategies and regulatory requirements.
- Lead meetings with internal and external stakeholders, conduct briefings with senior management, and resolve issues through information exchange, influence, strategic insight, and regulatory compliance.
- Leadership and Talent Management:
- Lead and review the work of a team of professionals and/or vendors who exercise latitude and independence in their assignments, ensuring alignment with technical, business, and regulatory objectives.
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.
Benefits & CompensationMedtronic 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.
About MedtronicWe 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
