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About the Role
Cala Health is seeking a motivated Product Manager to be the primary product owner for our physical device hardware and firmware portfolio. You will manage products through their lifecycle, define requirements, support roadmap execution, and ensure products meet user needs, clinical requirements, and business objectives. This hands-on role is ideal for a Product Manager experienced in FDA-regulated medical devices, working at the intersection of business, customer needs, hardware, software, and cross-functional execution.
Responsibilities
- 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.
Requirements
- Must have 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.
- DME experience.
- Experience with wearable medical devices, software-enabled or connected devices.
- 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.
Skills
- Product Management
- Hardware
- Firmware
- FDA-regulated medical devices
- Design Controls
- Human Factors Engineering (HFE)
- Usability studies
- Voice of Customer (VOC) research
- Data analysis
- Cross-functional leadership
- Communication
- DME experience
- Wearable medical devices
- Software-enabled devices
- Connected devices
Location
- Hybrid in San Mateo, CA
Work Type
- Hybrid
- Full-Time
- Exempt
Experience Level
- 3-5 years of experience within FDA-regulated medical devices
Salary/Compensations
- $140,000 - $165,000
About the Company
- At Cala, we’re working to free people from the burden of chronic disease.
- We began by creating the first non-invasive prescription therapy for hand tremor.
- Our products have empowered thousands of people to get back to their lives with confidence and ease.
- Our pioneering technology can be applied across neurology, cardiology, and so much more.
- It’s all part of our mission to help people in their struggle with chronic disease.
- We’re only just getting started.
Equal Opportunity
- Cala Health believes our success is based on diversity of people, teams and thinking.
- We offer all employees the tools, training and mentoring they need to succeed.
- Our selection process is driven by the key requirements for the role rather than bias or discrimination on the basis of a candidate’s sex, gender identity, age, marital status, veteran status, non-jobrelated disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification.