Senior PD Program Manager - NM/PH - Rice Creek/Fridley, MN (Onsite)
About The Position
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 Across our global Neuroscience organization, we advance care for some of medicine’s most complex neurological and spinal conditions. By combining innovative technology, data-driven insights, and deep clinical expertise, we partner with physicians and health systems to improve how patients are treated and supported throughout their care journey. 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.
Requirements
- Bachelor's degree in Engineering or Technical field with minimum of 7 years of relevant experience, OR Advance degree in Engineering or Technical field with minimum of 5 years of relevant experience
Nice To Haves
- MBA is preferred
- 5+ years of experience in project and/or people management
- Lean/Six Sigma Black Belt and Project Management certifications desired
- Experience leading MDR remediation programs
- 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 ability to interpret technical reports and statistical analysis
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Responsibilities
- 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.
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
