Sr. Project Manager, Product Development (Hardware)

$120,000 - $120,000/Yr

Tandem Diabetes Care - San Diego, CA

Full-time - Mid Level

San Diego, CA

Miscellaneous Manufacturing

About the position

Tandem Diabetes Care is seeking a Sr. Project Manager to oversee the design and commercialization of key new products. This role is pivotal in driving collaboration among cross-functional product commercial teams and serves as the internal liaison between engineering, marketing, manufacturing, regulatory affairs/quality assurance, and sales management. The Sr. Project Manager will be responsible for scheduling projects, ensuring timely launches, budgeting resources, and reporting on the progress of multiple projects simultaneously. This position plays a crucial role in the Tandem Product Commercialization Process (PCP), facilitating corporate Phase Review Discipline meetings and tracking progress with the Tandem Product Steering Committee (PSC). Additionally, the Sr. Project Manager will lead or participate in continuous improvement projects within product development, ensuring compliance with design control procedures and enhancing systems, procedures, and documentation as necessary. In this role, the Sr. Project Manager will plan and direct all aspects of software and systems projects, establishing project plans and objectives, developing cost analyses, managing schedules and budgets, and tracking progress. The individual will work closely with Product Management, Program Managers, and functional heads to resolve resource allocation issues and ensure projects are appropriately staffed and completed on time and within budget. The position also involves leading process improvement initiatives related to product development, resource management, and design controls, all aimed at enhancing cycle time, efficiencies, and compliance in medical device product development. Regular communication and presentation of project status updates to various organizational levels, including executive management, is a key responsibility. The Sr. Project Manager must ensure compliance with company policies, including Privacy/HIPAA and other legal and regulatory requirements, while also taking on additional responsibilities as assigned.

Responsibilities

• Manage the design and commercialization aspects of key new products.
• Drive collaboration among cross-functional product commercial teams.
• Act as the internal liaison between engineering, marketing, manufacturing, RA/QA, and sales management.
• Schedule projects and drive timely launches of multiple projects.
• Budget resources and report on the progress of projects.
• Facilitate corporate Phase Review Discipline meetings and track progress with the Tandem Product Steering Committee.
• Lead or participate in product development continuous improvement projects.
• Provide project management expertise and leadership from concept through commercialization.
• Plan and direct all aspects of software/systems projects.
• Establish project plans and objectives, develop project cost analysis, and manage project schedules and budgets.
• Work closely with Product Management, Program Managers, and functional heads to resolve resource allocation issues.
• Ensure efficient transfer of product from R&D to manufacturing and external marketing.
• Lead process improvement initiatives related to product development and compliance.
• Communicate and present regular project status updates to various levels of the organization.
• Ensure compliance with company policies and legal requirements.

Requirements

• Bachelor's degree in engineering or equivalent training.
• 2+ years' experience managing projects in FDA-regulated and ISO 14971 certified industry.
• 2+ years' experience in the medical device industry and compliance with internal Quality Systems.
• 2+ years' experience facilitating scrum ceremonies like sprint planning and retrospectives.
• Experience managing multiple scrum teams simultaneously.
• Experience managing projects from inception to post-market sustaining using phase-gate/agile methodology.
• Ability to work in a matrixed environment and establish influence across functional and vertical organizations.
• Ability to drive cultural change through best practices in project teams.
• Strong communication and influencing skills to manage project scope and resources.
• Ability to keep project teams focused and motivated to meet deadlines.
• Proficient in Project Management Tools, JIRA, and Confluence.
• Advanced skills in Microsoft Office, including Excel, PowerPoint, and MS-Project.
• Ability to maintain confidentiality and work under pressure.

Nice-to-haves

• Certificate in Project Management (PMP) and/or CSM (Certified Scrum Master) preferred.
• MBA preferred.
• Knowledge of DevOps, CI/CD, Business Intelligence, SaaS preferred.

Benefits

• Health care benefits including medical, dental, and vision insurance.
• Health savings accounts and flexible spending accounts.
• 10 paid holidays per year.
• A minimum of 20 days of paid time off starting in year 1.
• Access to a 401k plan with company match.
• Competitive compensation package including bonus and equity.