Calyxo-posted 12 months ago
$155,000 - $181,000/Yr
Full-time • Mid Level
Pleasanton, CA
11-50 employees
Miscellaneous Manufacturing

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resources each year. Our team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology. In this role, you will lead cross-functional teams through all phases of medical device development projects, ensuring timely delivery and alignment with business goals. You will effectively communicate project status, manage resources, identify risks, and ensure compliance with medical device regulations. You will also oversee the product development lifecycle and drive continuous improvement initiatives within the project management and product development processes.

  • Lead cross-functional teams through all phases of medical device development projects, including initiation, planning, execution, monitoring, and closing.
  • Effectively communicate project status, project risks, and major decisions.
  • Predict resources needed to reach goals and manage resources effectively.
  • Identify potential project risks and develop mitigation strategies.
  • Collaborate with internal and external stakeholders to align project objectives and drive results.
  • Ensure all project activities comply with medical device regulations and company quality systems.
  • Conduct regular design reviews, ensuring all design inputs and outputs are documented and aligned with regulatory and quality standards.
  • Manage third-party vendors, contractors, or outsourced teams as necessary.
  • Oversee the product development lifecycle, from concept to production transfer.
  • Collaborate with quality teams to define and execute software testing strategies.
  • Drive continuous improvement initiatives within the project management and product development processes.
  • BS degree in Software Engineering, Electrical Engineering, Biomedical Engineering, or a related field.
  • Minimum 5 or more years of project management within medical device.
  • Deep understanding of medical device software regulations, including ISO 13485, IEC 62304, FDA 21 CFR Part 11, and cybersecurity best practices.
  • Proficiency in software development tools, such as Git, Jira, Confluence, or other project management platforms.
  • Experience managing cross-functional teams, including developers, testers, quality assurance, and regulatory professionals.
  • Proven track record of managing complex product development projects and delivering high-quality products in a regulated environment.
  • Experience with Agile development methodologies (Scrum, Kanban) and project management tools (e.g., MS Project, Jira).
  • Strong analytical and problem-solving skills, with attention to detail and a focus on compliance and quality.
  • Master's degree or PMP certification.
  • Competitive salary range of $155,000 - $181,000
  • Stock options - ownership and a stake in growing a mission-driven company
  • Employee benefits package that includes 401(k), healthcare insurance, and paid time off
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