Program Manager (R&D) (Medical Devices)

Location: Hybrid work in Del Mar, California, with in-office attendance 2–3 days per week. Applicants must be authorized to work for any employer in the United States. Visa sponsorship is not available.

Salary: $120,000–$150,000 annually, plus bonus and benefits.

Company

hirify.global develops and manufactures diabetes technology, including insulin pump systems and automated insulin-delivery solutions.

What you will do

• Lead cross-functional core teams and complex software or system-level programs from concept through commercialization.
• Build and manage project plans, schedules, budgets, resource allocations, metrics, and status reporting.
• Drive compliance with Design Control procedures and support product development and design-change activities.
• Coordinate with the Program Office, project managers, functional leaders, executive management, and external partners.
• Support efficient transfer of products from R&D to manufacturing and external marketing.
• Lead process-improvement initiatives covering product development, resource management, design controls, efficiency, and compliance.

Requirements

• Experience working in complex matrixed organizations and influencing cross-functional stakeholders.
• Strong project leadership, communication, prioritization, problem-solving, and executive-influencing skills.
• Proficiency with project management tools, Microsoft Excel, PowerPoint, and MS Project.
• Experience with Engineering Change Orders, documentation, and review processes.
• Knowledge of Agile/Scrum, product development processes, engineering principles, and medical device practices.
• Authorization to work for any U.S. employer is required; visa sponsorship is unavailable.

Nice to have

• Bachelor’s degree in engineering or a related field.
• PMP certification or willingness to pursue certification; Scrum certification is a plus.
• At least four years of project management experience in FDA-regulated, ISO 14971-certified, or medical device environments.
• Experience with phase-gate development from project inception through post-market sustaining.
• Knowledge of FDA Design Controls, ISO Risk Management, medical device standards, and IEC 62304.

Culture & Benefits

• Medical, dental, and vision coverage available from the first day.
• Health savings and flexible spending accounts.
• At least 20 paid days off and 11 paid holidays per year.
• 401(k) plan with company match and Employee Stock Purchase plan.
• Workplace focused on innovation, employee well-being, inclusion, and collaboration.