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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

• 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 require