Program Manager (R&D)

Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience. Our human-centered approach to design, development, and support delivers innovative products and services for people who use insulin. Because many of our own team members live with diabetes or have a loved one impacted by diabetes, the work is personal, and we are committed to the cause.

About the role

The Program Manager (PM) leads cross-functional core teams and manages complex software projects and/or system-level programs through Tandem’s product development process, with the main goal of developing and delivering new medical device products to market. The Program Manager exemplifies the program management function and capabilities within Tandem and with external partners.

Key responsibilities include execution in a phase-gate process, leading or participating in core and scrum meetings, establishing and driving project plans and schedules, defining core team roles and responsibilities, setting project metrics, and ensuring compliance with Design Control procedures. The Program Manager also leads or participates in process improvement initiatives led by the PMO.

Responsibilities

• Provide project management expertise and leadership to a multi-functional core team from Concept through Commercialization, ensuring compliance with Design Control procedures and improvements of systems, procedures, and documentation.
• Plan and direct all aspects of software/systems projects/programs, including project plans, objectives, cost analysis, schedules, budgets, resource management, progress tracking, and status updates to management and external partners.
• Work closely with the Program Office, Project Managers, and functional heads to resolve resource allocation issues, conflicts, and priorities, ensuring projects are staffed appropriately, completed on time, and within budget.
• Ensure efficient transfer of product from R&D to manufacturing and external marketing.
• Lead or participate in process improvement initiatives related to product development, resource management, design controls, and other areas impacting cycle time, efficiencies, and compliance in medical device product development.
• Communicate and present regular and timely project status updates to various levels of the organization, including executive management and external partners.
• Perform other duties as required to support the PMO.

Schedule

Hybrid: This role will be a mix of in-office work at our corporate headquarters in Del Mar, CA and remote work. This position is expected to be in office 2-3 days per week but may vary depending on business demands.

Requirements

• Demonstrated success working in complex matrixed organizations and influencing cross-functional stakeholders.
• Proven ability to drive cultural change and implement project management best practices.
• Strong communication and executive-level influencing skills to manage scope, resources, and priorities.
• Skilled at leading, motivating, and aligning project teams to meet schedule and business objectives.
• Proficient with project management tools for planning, scheduling, task management, resource allocation, and collaboration.
• Advanced Microsoft Office expertise, including Excel (formulas, pivot tables, dashboards/graphs), PowerPoint, and MS Project.
• Experience with Engineering Change Orders (ECOs), documentation, and review processes.
• Excellent written and verbal communication skills with the ability to build strong internal and external partnerships.
• Strong organizational, prioritization, problem-solving, and decision-making abilities while maintaining confidentiality.
• Knowledge of Agile/Scrum methodologies, product development processes, engineering principles, and medical device industry practices.

Qualifications

• Bachelor’s degree in engineering or a related field; or a combination of education and applicable experience.
• Certificate in Project Management (PMP) is desired. Alternatively, willingness to pursue professional certification in the future.
• Scrum Certification is a plus.
• 4 years’ directly related experience in managing projects in FDA-regulated and ISO 14971 certified industry.
• 4 years’ experience in the medical device industry and compliance with internal Quality Systems.
• Experience in managing projects from inception to post-market sustaining using a phase-gate methodology.
• Experience in managing projects focused on solutions for people with diabetes is a plus.
• Knowledge and experience in implementing regulatory requirements for medical device development such as FDA’s Design Controls, ISO’s Risk Management and Medical Device standards, and ISO Software Development standards (e.g., IEC 62304).

Pay

The starting base pay range for this position is $120,000 to $150,000 annually. Base pay will vary based on job-related knowledge, skills, experience, and may fluctuate depending on candidate’s location and the overall job market. In addition to base pay, Tandem offers a competitive compensation package that includes a bonus and a robust benefits package.

Benefits

• Health care benefits including medical, dental, and vision available from your first day, as well as health savings accounts and flexible spending accounts.
• 11 paid holidays per year.
• A minimum of 20 days of paid time off (with accrual starting on day 1).
• Access to a 401k plan with company match.
• Employee Stock Purchase plan.