The Opportunity

Cala Health is seeking a highly motivated Product Manager to join our Product team and to serve as the primary product owner for our physical device hardware and firmware portfolio. You will be responsible for managing products across their lifecycle, from new product development through launch and sustaining. You will help define product requirements, support roadmap execution, and ensure products meet user needs, clinical requirements, and business objectives.

This is a hands-on role, well suited for a Product Manager with experience in FDA-regulated medical devices who enjoys working at the intersection of business, customer needs, hardware, software, and cross-functional execution, delivering products that exceed our customer expectations.

This role will work closely with Engineering, Clinical, Quality, Regulatory, Operations, and Commercial teams.

Title Product Manager
Reports to: Director of Product MarketingLocation: Hybrid in San Mateo, CA 3 days per week (Local candidates only)Employment type: Full-Time, ExemptPay range: $140,000 - $165,000Travel Requirement: Ability to travel up to 25% of the time.

A Day in the Life

Strategic Planning & Product Ownership:

• Serve as the primary product owner with full ownership of the product lifecycle.
• Collaborate with leadership to align product work with broader portfolio strategy and business priorities.

Product Development & Execution:

• Drive product roadmap execution, including hardware and firmware planning.
• Translate user, customer, and internal stakeholder needs into clear product requirements and documentation.
• Partner with Engineering, Quality, Regulatory, Clinical, and Operations to ensure compliance with FDA and quality standards.
• Lead new product introductions, including launch planning, cross-functional readiness, and performance tracking.

User & Data Insights:

• Act as the Voice-of-the-Customer by collecting usability feedback and market insights.
• Leverage data and metrics to make strategic, data-driven product decisions.

Lifecycle & Sustaining Management:

• Manage ongoing lifecycle activities, including improvements, cost reductions, issue resolution, and end-of-life planning.

Skills and Experience

Required:

Medical Device PM Experience:

• Must have 3-5 years of experience specifically within FDA-regulated medical devices.

Full Lifecycle Product Management:

• Ability to manage hardware-based products from development and launch through post-market improvements.

Technical Compliance & Usability:

• Expertise in Design Controls, requirements management, Human Factors Engineering (HFE), and usability studies.

Analytical & Market Research:

• Strong insight generation skills, including VOC (Voice of Customer) research and the ability to translate complex problems into actionable data.

Cross-Functional Leadership:

• Proven ability to lead diverse teams and balance multiple priorities in a fast-paced environment.

Collaborative Communication:

• Clear, structured communication style with a focus on building consensus and team success.

Preferred:

• DME experience.
• Experience with wearable medical devices, software-enabled or connected devices