Program Manager (R&D) (Medical Devices): Leading cross-functional software and system-level programs from concept through commercialization with an accent on phase-gate development, design controls, resource planning, and delivery of new diabetes technology products. Focus on coordinating complex matrixed teams, managing schedules and budgets, improving regulated product-development processes, and transferring products from R&D to manufacturing.
Location: Hybrid role based at the corporate headquarters in Del Mar, California, with in-office work 2–3 days per week. Applicants must be authorized to work for any employer in the United States.
Salary: $120,000–$150,000 annually, plus bonus and benefits.
Company
A medical technology company developing insulin delivery systems and connected products for people living with diabetes.
What you will do
Lead cross-functional core teams through concept, development, commercialization, and design-change activities.
Plan and manage software and system-level projects, including scope, schedules, budgets, resources, risks, and project metrics.
Drive execution through phase-gate product development and ensure compliance with Design Control procedures.
Coordinate with program management, project management, functional leaders, manufacturing, marketing, and external partners.
Present project status, risks, priorities, and resource needs to management and executive stakeholders.
Lead process-improvement initiatives focused on product development, resource allocation, design controls, efficiency, and compliance.
Requirements
Demonstrated success working in complex matrixed organizations and influencing cross-functional stakeholders.
Experience leading project teams, managing priorities and resources, and delivering against schedules and business objectives.
Proficiency with project management tools, including planning, scheduling, task management, resource allocation, and collaboration software.
Advanced Microsoft Office expertise, including Excel, PowerPoint, and MS Project.
Experience with Engineering Change Orders, documentation, review processes, Agile/Scrum, and product development.
Knowledge of medical device development practices, Design Controls, risk management, quality systems, and applicable software standards.
Nice to have
Bachelor’s degree in engineering or a related field.
PMP certification or willingness to pursue it, and Scrum certification.
At least four years of experience managing projects in FDA-regulated, ISO 14971-certified, or medical device environments.
Experience managing products from inception through post-market sustaining using a phase-gate methodology.
Experience with diabetes-related solutions and standards such as IEC 62304.
Culture & Benefits
Health, dental, and vision benefits available from the first day.
Health savings and flexible spending accounts.
At least 20 paid days off and 11 paid holidays annually.
401(k) plan with company match and an Employee Stock Purchase Plan.
Inclusive workplace focused on innovation, personal growth, collaboration, and employee well-being.
Hiring process
Employment is contingent on a pre-employment drug test and background check.
Background screening may include a review of criminal history because the role involves confidential and protected health information.
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