





Senior, niche regulated-medical-device Technical Product Owner role reduces applicant density despite metro location.
Requires regulated medical-device SDLC and domain-specific standards, making cross-industry transfer difficult.
Explicit 10+ years, 3+ years PO, and mandatory regulated-medical-device IEC/ISO compliance requirements demand strict filters.
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Own and manage the software backlog for next-generation medical device software components.
Translate complex clinical, business, and user needs into clear requirements and user stories to drive development.
Lead Agile ceremonies and collaborate cross-functionally to ensure compliant, high-quality software releases aligned with regulatory standards.
10+ years in software product development; at least 3 years in Product Owner or technical leadership role.
Bachelor’s or Master’s degree in Computer Science, Engineering, Biomedical Engineering, or related technical field.
Deep knowledge of software development in regulated/safety-critical environments with expertise in IEC 62304, ISO 13485, FDA, MDR standards.
Proven experience working within Agile/Scrum frameworks; strong documentation and communication skills.
Experienced in regulated medical device software development, balancing technical and regulatory priorities strategically.
Operates effectively as a cross-functional leader interfacing with engineering, quality, clinical, and regulatory teams.
Has a technical background (preferably including hands-on software development and C++ proficiency) enabling close collaboration with engineering teams.