Medical Device Product Manager — Hardware & Firmware

Cala Health, Inc.; San Francisco (CA); Hybrid; USD 140,000 - 165,000; Full time

Job summary

Cala Health is seeking a Product Manager to own the hardware and firmware portfolio across its lifecycle, from development through launch and sustaining. You will define product requirements, support roadmap execution, and ensure alignment with clinical and business objectives.

This hands-on role suits someone with FDA-regulated medical device experience who collaborates with Engineering, Clinical, Quality, Regulatory, Operations, and Commercial teams.

Qualifications

• Must have 3–5 years of experience specifically within FDA-regulated medical devices.
• Able to manage hardware-based products from development and launch through post-market improvements.
• Expertise in Design Controls, requirements management, Human Factors Engineering (HFE), and usability studies.
• Strong VOC (Voice of Customer) research and the ability to translate complex problems into actionable data.
• Proven cross-functional leadership in a fast-paced environment.

Responsibilities

• Serve as the primary product owner with full ownership of the product lifecycle.
• Drive product roadmap execution for hardware and firmware planning.
• Translate user and stakeholder needs into clear product requirements and documentation.
• Lead cross-functional readiness for launches and monitor performance.

Skills

Product management

Regulatory compliance

Requirements management

Design Controls

Tools

HFE

Job description

Cala Health is seeking a Product Manager to own the hardware and firmware portfolio across its lifecycle, from development through launch and sustaining. You will define product requirements, support roadmap execution, and ensure alignment with clinical and business objectives.

This hands-on role suits someone with FDA-regulated medical device experience who collaborates with Engineering, Clinical, Quality, Regulatory, Operations, and Commercial teams.