Product Manager

calahealth; United States; Hybrid; USD 140,000 - 165,000; Full time

Benefits offered by this job

Travel up to 25%

Job summary

Cala Health is seeking a hybrid Product Manager to lead a portfolio of FDA-regulated medical device hardware and firmware products through full lifecycle, collaborating with engineering, clinical, regulatory, quality, and commercial teams. You will own hardware and firmware from concept to launch and sustainment, translate stakeholder needs into clear requirements, and drive post-market improvements.

You will work across disciplines to ensure Design Controls, usability studies, and VoC insights

Qualifications

• 3–5 years of experience as a Product Manager specifically within FDA-regulated medical devices.
• Demonstrated ability to manage hardware-based products from development through post-market sustainment
• Expertise in Design Controls, requirements management, Human Factors Engineering (HFE), and usability studies
• Strong Voice-of-Customer research skills and the ability to convert complex problems into actionable data
• Proven cross-functional leadership and ability to balance multiple priorities in a fast-paced environment
• Clear, structured communication style with a focus on consensus-building

Responsibilities

• Serve as primary product owner for hardware and firmware, managing the full lifecycle from concept through launch and post-market improvements
• Translate user, customer, and stakeholder needs into clear product requirements and documentation
• Partner with engineering, quality, regulatory, clinical, and operations teams to maintain FDA and quality compliance
• Lead new product introductions, including launch planning, cross-functional readiness, and performance tracking
• Collect usability feedback and market insights to serve as the Voice-of-Customer
• Manage ongoing lifecycle activities including improvements, cost reductions, issue resolution, and end-of-life planning

Skills

FDA-regulated devices

Hardware systems

Design Controls

Requirements management

HFE

Usability studies

Voice-of-Customer

Cross-functional leadership

Job description

Role overview

A hybrid Product Manager opportunity leading a portfolio of FDA-regulated medical device hardware and firmware products through their full lifecycle. The role sits at the intersection of engineering, clinical, regulatory, quality, and commercial teams, driving products from development through launch, sustainment, and end-of-life planning.

Responsibilities

• Serve as primary product owner for hardware and firmware, managing the full lifecycle from concept through launch and post-market improvements
• Translate user, customer, and stakeholder needs into clear product requirements and documentation
• Partner with engineering, quality, regulatory, clinical, and operations teams to maintain FDA and quality compliance
• Lead new product introductions, including launch planning, cross-functional readiness, and performance tracking
• Collect usability feedback and market insights to serve as the Voice-of-Customer
• Manage ongoing lifecycle activities including improvements, cost reductions, issue resolution, and end-of-life planning

Requirements

• 3–5 years of experience as a Product Manager specifically within FDA-regulated medical devices
• Demonstrated ability to manage hardware-based products from development through post-market sustainment
• Expertise in Design Controls, requirements management, Human Factors Engineering (HFE), and usability studies
• Strong Voice-of-Customer research skills and the ability to convert complex problems into actionable data
• Proven cross-functional leadership and ability to balance multiple priorities in a fast-paced environment
• Clear, structured communication style with a focus on consensus-building

Nice to have

• Durable Medical Equipment (DME) experience
• Background with wearable medical devices, software-enabled, or connected devices

Benefits and work setup

• Hybrid role based in San Mateo, CA, with three days per week on-site (local candidates only)
• Full-time, exempt position
• Compensation range of $140,000 - $165,000
• Up to 25% travel required