Program Manager (R&D)

TL;DR

Program Manager (R&D) (Medtech): Leading cross-functional core teams to develop and deliver new medical device products with an accent on FDA compliance and software system-level programs. Focus on managing the product life cycle through phase-gate processes and ensuring adherence to Design Control procedures.

Location: Hybrid: Must be based in Del Mar, CA (in-office 1-2 days per week).

Salary: $120,000 – $150,000

Company

hirify.global develops innovative insulin delivery systems and technology to improve the lives of people with diabetes.

What you will do

• Lead cross-functional core teams through the product development process from Concept to Commercialization.
• Plan and direct software and system-level programs, including budgeting, resource management, and scheduling.
• Drive execution using phase-gate processes and lead core and scrum meetings.
• Ensure compliance with Design Control procedures and internal Quality Systems.
• Communicate project status and updates to executive management and external partners.
• Lead process improvement initiatives within the PMO to optimize cycle time and efficiency.

Requirements

• Bachelor’s degree in engineering or a related field.
• 4+ years of experience in FDA-regulated and ISO 14971 certified industries.
• 4+ years of experience in the medical device industry.
• Knowledge of FDA Design Controls, ISO Risk Management, and IEC 62304.
• Must be authorized to work in the U.S. (no sponsorship provided).
• Proficiency with MS Project, Excel, and PowerPoint.

Nice to have

• PMP or Scrum certification.
• Experience with diabetes-focused medical solutions.

Culture & Benefits

• Health care benefits (medical, dental, vision) available from day one.
• 401k plan with company match and Employee Stock Purchase plan.
• Minimum of 20 days PTO plus 11 paid holidays per year.
• Flexible hybrid work arrangement (1-2 days in office).
• Inclusive, human-centered workplace culture focused on innovation and people.