We anticipate the application window for this opening will close on - 15 Oct 2025

 

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

The Diabetes Group at Medtronic is part of Medtronic PLC, the global leader in medical technology. We are committed to ongoing breakthrough developments in leading-edge technology, unrivaled service and support, and uncompromising leadership. Medtronic is working with the global community to change the way people manage diabetes. Together, we will transform diabetes care by expanding access, integrating care and improving outcomes, so people with diabetes can enjoy greater freedom and better health.

We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

The Sr Program Manager - Development Process & Compliance will be responsible to lead/co-lead the Product Development processes encompassing design controls.

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

• Leads or leverages cross functional teams to evaluate, develop and manage projects for existing product development processes and ongoing PDP lifecycle process management.
• Identifies and leads PDP improvement initiatives including stakeholder management, driving vision to implementation and training strategies.
• Oversees and manages the operational aspects of ongoing projects and serves as liaison to project teams to represent the PDP process.
• Manages the development and implementation process of a company’s products and services involving departmental or cross-functional teams focused on the delivery of new or existing products and processes.
• Provides support and guidance to Program Management Leaders and cross functional team members on navigating through product development activities through the product lifecycle ensuring compliance with regulations and standards.
• This role is critical to ensuring that products meet regulatory requirements and quality standards throughout the design process. In this role you will help mitigate risks, ensure compliance with relevant regulations, and maintain product integrity.
• Proactive individual with expert level understanding of design controls and ability to apply knowledge to influence product development Standard Operating Procedures and provide guidance to Product Innovation leaders.
• Experienced auditing design history files to ensure compliance with regulations and standards.
• Monitor changes in regulations and update internal procedures as needed.
• Must be a strong team player with excellent communication skills that will drive optimization of design control processes in collaboration with Quality, Regulatory & other key stakeholders’ groups.
• Experience with cross functional project teamwork and collaboration with R&D, QA, RA, Marketing, Usability and Manufacturing team members. 
• Strong team building and knowledge sharing skills to establish best practices, train and develop team members. 
• Implement industry best practices and provide training, establish compliance metrics, and address or escalate issues for resolution. 

This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.

Must Have: Minimum Requirements 

To be considered for this role, please ensure the minimum requirements are evident on your resume.

•   Bachelor’s degree and 7 years of relevant experience, or advanced degree and 5 years of relevant experience 

Nice to Have:     

•    MBA preferred
•    PMP Certification and/or certifications related to Quality
•    Technical degree is a plus.
•    Experience with Design Control documentation within medical device industry or Pharma industry.
•    Experience conducting and organizing training, mentoring, and guidance for cross functional teams through design control and regulation requirements.
•    Excellent written and verbal communication skills; ability to present infor