5 - 8 years

10 - 15 Lacs

Posted:21 hours ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

The Senior Technical Product Owner (TPO) will lead the definition, prioritization, and delivery of software features for next-generation medical device platforms. This role acts as the primary interface between product management, engineering, quality, and regulatory teams to ensure software solutions meet clinical needs, regulatory standards, and business objectives.
Key responsibilities include managing the software backlog, translating vision into actionable requirements, driving cross-functional alignment, overseeing development processes (Agile/Scrum and V-Model), and ensuring compliance with medical device standards. The TPO will also lead risk management activities, facilitate Agile ceremonies, and mentor junior team members.
Core Responsibilities:
  • Own and manage the software backlog for medical device software components.
  • Translate clinical, business, and user needs into user stories and functional specifications.
  • Collaborate with engineering, QA, UX, and regulatory teams for cohesive delivery.
  • Oversee software development using Agile/Scrum and V-Model methodologies.
  • Define and optimize process flows for medical device software development.
  • Lead planning, execution, and monitoring of end-to-end product development.
  • Make data-driven prioritization decisions balancing technical and regulatory needs.
  • Ensure compliance with IEC 62304, ISO 13485, ISO 14971, and related standards.
  • Facilitate Agile ceremonies and manage stakeholder expectations.
  • Mentor junior Product Owners and engineers.
Required Qualifications:
  • Education: Bachelor s or Master s degree in Computer Science, Engineering, Biomedical Engineering, or related technical field.
  • Experience:
    • 15+ years in software product development.
    • Minimum 5 years in a Product Owner or technical leadership role, preferably in medical devices or regulated environments.
  • Expertise:
    • Regulatory SDLC knowledge for safety-critical environments.
    • Proven experience with Agile/Scrum and V-Model methodologies.
    • Strong documentation and compliance skills.
  • Standards Knowledge: IEC 62304, ISO 13485, FDA, MDR.
  • Soft Skills: Exceptional communication, stakeholder management, and leadership abilities.
Preferred Qualifications:
  • Domain experience in medical devices, diagnostics, surgical systems, or ophthalmology.
  • Hands-on software development background.
  • Strong understanding of verification/validation and risk management processes.
  • Cybersecurity knowledge (FDA Premarket Guidance, ISO/IEC 27001).
Your ZEISS Recruiting Team:
Upasana Sinal

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Zeiss Pharmaceuticals logo
Zeiss Pharmaceuticals

Pharmaceuticals

New York

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