Product Manager

The role

The Product Manager serves as the primary product owner for physical device hardware and firmware. You will manage products across their lifecycle from development through launch and sustaining.

What you will do

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

Required qualifications

• 3–5 years of experience specifically within FDA-regulated medical devices.
• Ability 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 insight generation skills, including VOC (Voice of Customer) research and the ability to translate complex problems into actionable data.
• Proven ability to lead diverse teams and balance multiple priorities in a fast-paced environment.
• Clear, structured communication style with a focus on building consensus and team success.

Nice to have

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

Before you apply

• Applicants must be authorized to work in the United States on a full-time basis, or eligible for work authorization through a sponsorship path that Cala Health is able to support.
• Sponsorship decisions are made individually and are not guaranteed.

About the company

Cala Health is working to free people from the burden of chronic disease. They created the first non-invasive prescription therapy for hand tremor.