lead software development projects as Epic Owner in a medical device context
plan, coordinate, and guide project execution in alignment with regulatory requirements and design control processes
own projects and collaborate closely with product owners, product managers, commercial teams, hardware/embedded software specialists, and regulatory affairs
work in close collaboration with design control leads for documentation, traceability, and regulatory compliance
monitor essential KPIs and guide early risk-reduction measures
guide the GN product development lifecycle and continuously enhance processes
represent project teams in governance and reporting, including milestone reviews with quality and regulatory stakeholders

experience delivering software in a regulated environment
medical devices, pharma, or similar (experience with IEC 62304, ISO 13485, FDA, or EU MDR)
understand how design control, traceability, and verification/validation activities integrate into agile delivery
delivered software solutions in an agile/SAFe environment
experience with hardware or embedded systems
hold a relevant technical degree or equivalent experience
familiar with project management methods (PMP, Prince2 beneficial)
interested in process improvement and AI-enabled ways of working
proficient in English, both orally and in writing

Software Project Manager

Key skills