Manager of software engineering állás, munka

POSITION DESCRIPTION We are seeking an experienced and motivated professional to join our software quality assurance team. In this key role, you will help ensure compliance with IVDR, FDA 21 CFR Part 820, and cybersecurity requirements for medical device software. - Partner with development teams...

• Independently lead cross-functional teams through the full product lifecycle-from concept to market launch, ensuring alignment with business strategy.
• Lead and deliver complex hardware and software automation development programs with global impact.

• Product Management for electric-acoustic solutions and related objective measures
• End-to-end product lifestyle management: from requirements gathering and development support to launch activities and in-life management
• Delivery of presentations and training for employees, professionals, and recipients

• Drive commercial success by collaborating with German sales teams and distribution partners.
• Spearhead the launch of new technologies and indications in the German market.
• Support the transition to a direct sales model and the commercialisation of UK operations in Germany.

• Drive regulatory strategy for new product launches, ensuring proactive and effective planning aligned with global requirements
• Lead a team of regulatory experts in External Devices & Software within Regulatory Affairs

• Develop and implement global regulatory pathways for product authorizations
• Oversee preparation and submission of regulatory documents to authorities

• design hard- and software solutions to address intraoperative workflow problems of surgeons
• gather and integrate customer feedback to refine your designs
• build proof-of-concept demonstrators and test your solutions with product management and clinical partners

• Develop cutting-edge optical smart instruments and medical imaging devices, utilizing multiple optical sensing modalities with a focus on medical robotics applications
• Test concepts, core functionalities, and analyze data generated by optical sensing-based hardware and software

• You are responsible for quality related topics like change control, deviations and/or complaints related to DS products at CMOs
• Define together with the CMO effective CAPAs and track the timely implementation

• Derive, structure, and prioritize user stories to guide development based on stakeholder requirements
• Coordinate interdisciplinary and cross-functional teams to implement new features effectively
• Guide and instruct the development team, managing technical dependencies to ensure smooth progress