Lead Engineer-Technical Product Owner – Medical Device Software

NeST Digital; Bengaluru; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

NeST Digital is seeking a Technical Product Owner for medical device software to lead definition, prioritization, and delivery of features across regulatory-compliant platforms. You will coordinate with product management, engineering, QA, and regulatory teams to ensure patient safety and clinical effectiveness.

The role requires 10+ years in software product development, 3+ years in a PO or technical leadership role, deep regulatory SDLC knowledge (IEC 62304, ISO 13485, FDA MDR), and strong

Qualifications

• Education: Bachelor's or Master's in Computer Science, Engineering, Biomedical Engineering, or related technical field.
• 10+ years in software product development with at least 3 years in a Product Owner or technical leadership role.
• Regulatory SDLC expertise: deep knowledge of software development within regulated or safety-critical environments.
• Agile experience: proven experience delivering software using Agile/Scrum frameworks with strong documentation skills.
• Medical Device Standards: solid understanding of IEC 62304, ISO 13485, FDA, MDR, and related standards.
• Communication: exceptional communication and stakeholder management skills with a collaborative, cross-functional mindset.

Responsibilities

• Own the Software Backlog: Lead and manage the product backlog for medical device software component.
• Translate Vision to Execution: Transform complex clinical, business, and user needs into clear user stories, requirements, and functional specs that drive development.
• Drive Cross-Functional Alignment: Collaborate closely with software engineers, QA, UX designers, systems engineers, and regulatory teams to ensure cohesive, high-quality delivery.
• Prioritize for Impact: Make data-informed decisions to balance development, technical debt, and regulatory considerations-ensuring high product value and compliance.
• Ensure Scalable Architecture: Partner with system architects to develop solutions that are scalable, secure, and maintainable.
• Maintain Regulatory Rigor: Contribute to risk management activities including hazard analysis, design traceability, and documentation in compliance with IEC 62304 and ISO 14971.
• Lead Agile Execution: Facilitate Agile ceremonies-sprint planning, backlog grooming, cross-functional syncs-ensuring on-time, compliant software releases.

Skills

Backlog management

Agile/Scrum

Regulatory SDLC

C++

Communication

Education

Bachelor's or Master's in Computer Science/Engineering/Biomedical Engineering

Job description

Technical Product Owner - Medical Device Software

About The Role

We are seeking a Technical Product Owner (TPO) to lead the definition, prioritization, and delivery of software features for our next-generation medical device platforms. In this critical role, you will serve as the key interface between product management, engineering, quality, and regulatory teams-ensuring software solutions align with clinical needs, regulatory standards, and business objectives.

Key Responsibilities

• Own the Software Backlog: Lead and manage the product backlog for medical device software component.
• Translate Vision to Execution: Transform complex clinical, business, and user needs into clear user stories, requirements, and functional specs that drive development.
• Drive Cross-Functional Alignment: Collaborate closely with software engineers, QA, UX designers, systems engineers, and regulatory teams to ensure cohesive, high-quality delivery.
• Prioritize for Impact: Make data-informed decisions to balance development, technical debt, and regulatory considerations-ensuring high product value and compliance.
• Ensure Scalable Architecture: Partner with system architects to develop solutions that are scalable, secure, and maintainable.
• Maintain Regulatory Rigor: Contribute to risk management activities including hazard analysis, design traceability, and documentation in compliance with IEC 62304 and ISO 14971.
• Lead Agile Execution: Facilitate Agile ceremonies-sprint planning, backlog grooming, cross-functional syncs-ensuring on-time, compliant software releases.

Required Qualifications

• Education: Bachelor's or Master's degree in Computer Science, Engineering, Biomedical Engineering, or a related technical field.
• Experience: 10+ years in software product development, with at least 3 years in a Product Owner or technical leadership role.
• Regulatory SDLC Expertise: Deep knowledge of software development within regulated or safety-critical environments.
• Agile Experience: Proven experience delivering software using Agile/Scrum frameworks, with strong documentation skills.
• Medical Device Standards: Solid understanding of IEC 62304, ISO 13485, FDA, MDR, and related standards.
• Communication: Exceptional communication and stakeholder management skills with a collaborative, cross-functional mindset.

Preferred Qualifications

• Domain Experience: Background in medical devices, diagnostics, surgical systems, or ophthalmology.
• Technical Background: Hands-on experience in software development, with preferred proficiency in C++.
• Cybersecurity Acumen: Familiarity with secure software development and frameworks such as FDA Premarket Cybersecurity Guidance and ISO/IEC 27001.
• Cutting-Edge Innovation: Work on advanced medical devices and imaging systems that are transforming surgical precision and patient care.
• Security-First Culture: Be part of a team that prioritizes cybersecurity and patient safety, with a strong focus on secure software development and regulatory excellence.
• Global Collaboration: Collaborate with expert teams in Germany, the U.S., and across the globe on high-impact, next-gen healthcare solutions.
• People-Centric Leadership: Grow in a culture that values mentorship, learning, and long-term career development.
• Stability & Purpose: Join a 175-year-old brand that combines legacy, stability, and cutting-edge innovation with a clear mission to make a difference in people’s lives.