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

Seeking a dynamic and seasoned Senior Program Manager to drive cross-functional programs as part of the Neuromodulation (NM) and Pelvic Health (PH) operations product lifecycle management team. This team manages complex projects and programs in the released product space, including regulatory (i.e. MDR) compliance remediation, manufacturing capacity expansion, product design enhancement, and supply continuity programs.

Products in these therapy areas include implantable and external neurostimulators, implantable infusion pumps, leads, catheters, associated software programming applications, and associated device recharge and programming instruments.

The ideal candidate has demonstrated prior success in leading diverse and multi-site projects which includes matrixed team members from R&D, test, biocompatibility, sterilization, regulatory affairs, operations, supply chain, and quality, among others. This role requires a combination of technical expertise, program management skills, business acumen, and domain knowledge in medical device operations and development.

This is a hybrid position with the expectation of being onsite at Medtronic’s Rice Creek, Villalba, and/or Juncos facility ~3 days/week.

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

• Develop and maintain project plans, schedules, and resource allocation for assigned programs, ensuring alignment with business strategies and applicable medical device regulations.
• Facilitate effective communication among stakeholders, providing regular updates on project progress and strategic impact
• Manage technical risks and issues by working with the technical team to develop and maintain risk burndown plans
• Reviews status of projects and budgets; manages schedules and prepares status reports.
• Assesses project issues and develops resolutions to meet productivity, quality, and client-satisfaction goals and objectives.
• Develops mechanisms for monitoring project progress and for intervention and problem solving.
• Gathers requirements, works on requirements planning, requirements elicitation and requirements management to ensure they meet demands of project’s key stakeholders.
• Communicates with stakeholders, obtains stakeholder engagement to ensure the end products or processes will solve the business problems.

Minimum Requirements

• Bachelor’s degree required
• Minimum of 7 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience

• Experience with design and manufacturing of medical devices
• Experience with regulatory submissions and FDA regulations (e.g. 510k, PMA)
• Experience working with quality systems with a comprehensive understanding of elements in design history files and device master records.
• Knowledge of medical device standards and regulations (e.g., IEC 60601, IEC 62304, ISO 14971, ISO 13485).
• Strong critical thinking and problem-solving skills in a team environment
• Strong communication and teamwork skills; builds trusting relationships with team members and key leadership stakeholders
• Excellent written and verbal communication skills; ability to present information to cross functional audiences including management
• Extensive experience with MS Project or similar software
• Strong ability to interpret technical reports and statistical analysis
• High degree of initiative and self-motivation

Nice to Have

• BS or Advanced degree in Engineering or a technical discipline
• Masters in Business Administration
• 10+ years of experience in Project and/or People Management
• Lean/Six Sigma Black Belt
• Project Management Certifications are a plus (PMP, SMC, CSM, DASM, PMI-ACP)
• Experience leading MDR remediation programs

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