Technical Product Owner (m/f/d)

Technical Product Owner (m/f/d)

Position Summary

We are seeking a dynamic and experienced Product Owner to drive the development of software solutions for Heart-Lung Machines and other critical medical devices. As a key liaison between stakeholders and the development team, you will be responsible for defining product requirements, ensuring alignment with regulatory standards, and prioritizing features to deliver high-quality, compliant, and user-centric medical device software. Your expertise in Agile methodologies, medical device software development, and IEC 62304 compliance will be crucial in delivering innovative and safe solutions.

General Responsibilities

• Define and manage the product backlog, ensuring that requirements align with business goals and regulatory standards

• Act as the bridge between stakeholders and development teams, translating customer needs and regulatory requirements into clear, actionable user stories

• Collaborate with cross-functional teams, including software architects, engineers, quality assurance, and regulatory experts, to deliver safe and efficient software solutions

• Ensure compliance with IEC 62304, ISO 13485, and ISO 14971 standards throughout the product development lifecycle

• Engage with end-users and key stakeholders to gather feedback and drive continuous improvement in the product

• Work closely with regulatory and quality teams to ensure documentation and validation processes are met

• Occasional travel may be required

Skills and Experience

• Bachelor’s or master’s degree in engineering, Computer Science, Biomedical Engineering, or a related field

• Experience in product ownership, product management, or software development within the medical device industry

• Certified Scrum Product Owner (CSPO) or equivalent Agile certification / Experience in agile development methodologies within regulated environments

• Knowledge of IEC 62304, ISO 13485, and ISO 14971 regulatory frameworks for medical device software (nice to have)

• Experience working with software development teams best case in embedded and real-time systems

• Experience with product lifecycle management (PLM) tools and Agile software tools (e.g., Jira, Azure DevOps)

• Knowledge of medical device software validation and verification (V&V) processes

• Understanding of Human-Machine Interface (HMI) development and embedded Linux systems is a plus

• Excellent communication and stakeholder management skills

• Fluent English language skills, German would be a pus

• Strong analytical and problem-solving capabilities

• Ability to prioritize and manage multiple projects in a fast-paced, regulated environment

• Leadership skills to drive cross-functional collaboration and decision-making

• Strong attention to detail and commitment to quality

WHAT WE CAN OFFER YOU

In addition to providing you with a supportive, inclusive and collaborative environment where you will feel empowered to take ownership and drive meaningful change, we will reward you with the following:

• A dynamic role in an advanced Medical Device environment interfacing with all worldwide regulatory landscapes supporting your professional career growth

• Exposure to a State-of-the-Art medical device development process, in close co-operation with international clinicians

• Competitive base salary

• Variable short-term & long-term incentives

• Recognition: through our STARS Program, we recognize and celebrate our colleagues’ contributions and achievements

If you like the sound of the above and feel energized by the idea of joining a great brand at a moment of exciting expansion, please apply now. We look forward to hearing from you!