Program Manager (R&D)

Tandem Diabetes Care, Inc.; San Diego (CA); Hybrid; USD 120,000 - 150,000; Full time

Benefits offered by this job

Bonus eligibility

Health benefits

11 paid holidays

Minimum 20 days paid time off

401(k) with company match

Employee Stock Purchase Plan

Job summary

Tandem Diabetes Care, Inc. in Del Mar, CA is seeking a Program Manager to lead cross-functional software and system-level programs through product development and the phase-gate process, from concept to commercialization.

The role requires 4+ years in FDA-regulated medical devices, strong Design Controls knowledge, and excellent communication. Hybrid work with 2-3 days in the office at our Del Mar headquarters is expected.

Qualifications

• 4+ years managing projects in FDA-regulated environments.

Responsibilities

• Lead cross-functional core teams from concept through commercialization.
• Develop and manage project plans, budgets, and schedules.
• Ensure compliance with Design Control procedures and ISO 14971.
• Provide regular project status updates to management and partners.
• Collaborate with R&D, manufacturing, and regulatory teams to remove roadblocks.

Skills

Project management

Cross-functional leadership

Executive communication

Agile/Scrum

Resource planning

Education

Bachelor's degree in engineering or related field

PMP or Scrum Certification desired

Tools

MS Project

Excel

PowerPoint

Job description

GROW WITH US:Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience. We’d love for you to team up with us to “innovate every day,” put “people first,” and take the “no-shortcuts” approach that has propelled us to become a leader in the diabetes technology industry.STAY AWESOME:Tandem Diabetes Care is proud to manufacture and sell the Tandem Mobi system and t:slim X2 insulin pump with Control-IQ+ technology — an advanced predictive algorithm that automates insulin delivery. But we’re so much more than that. Our company’s 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. Learn more at tandemdiabetes.comA DAY IN THE LIFE: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 is expected to exemplify the program management function and capabilities within Tandem and external partners. Key elements of the function include: execution in a phase gate process that defines development team deliverables throughout the product life cycle, lead/participate in core and scrum meetings, establish and drive the team’s project plan and schedule with clearly defined core team roles and responsibilities, establish project metrics, execute PM responsibilities as defined by our Design Control procedures. The Program Manager is also expected to lead or participate in process improvement initiatives led by the PMO.Program Manager's at Tandem are also responsible for:Provides project management expertise and leadership to a multi-functional core team from Concept through Commercialization following Tandem’s standard process for product development and/or Design change; ensures implementation and compliance to Design Control procedures and improvements of systems, procedures, and documentation.Plans and directs all aspects of software/systems projects/programs. Establishes project plans and objectives, develops project cost analysis, establishes, and manages the project schedule and budget, manages resources, tracks progress, and provides updates to management and external partners. Works closely with the Program Office, Project Managers, and functional heads to resolve resource allocation issues, conflicts, and priorities and to ensure projects are staffed appropriately, completed on time, and within budget constraints. Ensures efficient transfer of product from R&D to manufacturing and external marketing.Leads/participates in process improvement initiatives related to product development, resource management and allocation, design controls, and other areas that impact cycle time, efficiencies, and compliance in medical device product development.Communicates and presents regular and timely project status updates to various levels of the organization including the executive management team and external partners.As necessary, performs other duties as required to support the PMO.WHEN & WHERE YOU’LL WORK: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.WHAT YOU’LL NEED: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.EXTRA AWESOME: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, should be willing to pursue professional certification in the future.Scrum Certification 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 to 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 a plus.Knowledge and experience in the implementation of regulatory requirements for medical device development such as FDA’s Design Controls, ISO’s Risk Management and Medical Device standards, ISO Software Development standards (e.g., IEC 62304).COMPENSATION & BENEFITS: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 also fluctuate depending on candidate’s location and the overall job market. In addition to base pay, Tandem offers a competitive compensation package that includes bonus and a robust benefits package.Tandem offers health care benefits such as medical, dental, vision available your first day, as well as health savings accounts and flexible saving accounts. You’ll also receive 11 paid holidays per year, a minimum of 20 days of paid time off (with accrual starting on day 1) and you will have access to a 401k plan with company match as well as an Employee Stock Purchase plan. Learn more about Tandem’s benefits here!YOU SHOULD KNOW:Qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable state and local Fair Chance laws and regulations. A conditional offer of employment from Tandem is contingent upon successful completion of a pre-employment screening process comprised of a drug test (excluding marijuana) and background check, which includes a review of criminal history information.Tandem has good cause to conduct a review of criminal history information of candidates for this position, as this role may involve access to proprietary, sensitive and/or confidential information, including customer protected health information. This review is required to ensure that individuals in such roles uphold high standards of trust and integrity so as to protect the interests of our customers, employees, and stakeholders.SPONSORSHIP:Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.WHY YOU’LL LOVE WORKING HERE:At Tandem, we believe joy fuels excellence. That's why we've built a workplace that celebrates your achievements and supports your well-being. Our team thrives on pushing boundaries and fostering growth, all while maintaining a spirit of fun and camaraderie. This is just one of the ways we stay awesome! Explore the benefits and reasons to love Tandem at https://www.tandemdiabetes.com/careers.BE YOU, WITH US!We embrace the value that every single one of us brings to the table. But sometimes we forget that when we don’t meet 100% of a job description’s criteria – maybe you’re feeling that way right now? We encourage you to apply anyway. Because we want you to be you, with us.Tandem is firmly committed to being an equal opportunity employer and does not discriminate on the basis of age, disability, sex, race, religion or belief, gender identity or expression, marriage/civil partnership, pregnancy/maternity, or sexual orientation. We are an inclusive organization, and we welcome applications from a wide range of candidates. Selection for roles will be based on individual merit alone.REFERRALS:We love a good referral! If you know someone who would be a great fit for this position, please share!APPLICATION DEADLINE:The position will be posted until a final candidate is selected for the requisition or the requisition has a sufficient number of applications.Make a move that matters. Join Tandem Diabetes Care, where we're turning challenges into triumphs every day and where your talents will help shape a healthier, happier tomorrow.#LI-KT1 #LI-Hybrid