Lead Engineer-Technical Product Owner Medical Device Software

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

As a Technical Product Owner, you will:

• 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.

• Education: Bachelors or Masters 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.

• 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 peoples lives.