Medtronic
Senior Program Manager - Neuro Science
Medtronic, Minneapolis, Minnesota, United States, 55400
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 LifeSeeking 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
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.
Review status of projects and budgets; manage schedules and prepare status reports.
Assess project issues and develop resolutions to meet productivity, quality, and client-satisfaction goals and objectives.
Develop mechanisms for monitoring project progress and for intervention and problem solving.
Gather requirements, work on requirements planning, requirements elicitation and requirements management to ensure they meet demands of project’s key stakeholders.
Communicate with stakeholders, obtain 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 RequirementsThe 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.
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.
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.
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A Day in the LifeSeeking 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
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.
Review status of projects and budgets; manage schedules and prepare status reports.
Assess project issues and develop resolutions to meet productivity, quality, and client-satisfaction goals and objectives.
Develop mechanisms for monitoring project progress and for intervention and problem solving.
Gather requirements, work on requirements planning, requirements elicitation and requirements management to ensure they meet demands of project’s key stakeholders.
Communicate with stakeholders, obtain 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 RequirementsThe 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.
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.
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.
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