Technical Product Owner

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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

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