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Cala HealthPosted 3 weeks ago

Product Manager

$140,000–$165,000 year

HybridSan Mateo, California, United States

Full TimeSmallHealthcare

Job Summary

Own the product lifecycle for the physical device hardware and firmware portfolio, driving roadmap execution from new product development through launch and sustaining. Translate user, customer, and stakeholder needs into clear requirements while collaborating with Engineering, Clinical, Quality, Regulatory, and Operations teams to ensure FDA and quality compliance. Lead new product introductions, manage ongoing improvements and cost reductions, and leverage data-driven insights to make strategic decisions. Serve as the primary product owner, aligning work with broader portfolio strategy and business priorities to deliver products that exceed customer expectations.

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
  • Expertise in requirements management
  • Expertise in Human Factors Engineering (HFE)
  • Expertise in usability studies
  • Strong insight generation skills, including VOC (Voice of Customer) research
  • Ability to translate complex problems into actionable data
  • Proven ability to lead diverse teams
  • Ability to balance multiple priorities in a fast-paced environment
  • Clear, structured communication style
  • Ability to build consensus
  • Focus on team success
  • Ability to travel up to 25% of the time
  • Location: San Mateo, CA (Local candidates only)

Desired Qualifications

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

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