Senior Software Program Manager (m/w/d) Medical Devices - fixed term for 1-2 years

As a software program manager and product owner, you are responsible for one of our devices within the Microsurgery or Surgery product line. You work closely with product management, your software development team and other experts (quality management, regulatory/clinical affairs, localization) that help you to plan, develop, and launch the next versions of a highly challenging and interesting digital medical device in microsurgery.

In your role, you are responsible for the software development process end-to-end and oversee both the compliance with our quality management and regulatory processes as well as a customer-centric development of the software product. You coordinate with relevant stakeholders, ensure timely delivery of the software and provide implementation and roll-out plans.

You will get insights into the development of digital solutions for patient care that helps our customers to increase their patient’s quality of life.

• Interims -Program and software project management (e.g., breaking down a product roadmap into deliverables and versions, project planning with quality gates required for medical devices)

• Planning, creation, and review of product documentation for regulatory approval (FDA 510(k), MDD and MDR) in compliance with IEC 62304, ISO 13485, ISO 14971, IEC 62366 standards

• Responsibility and preparation of project and budget plans including project controlling and external contracting

• Coordinating project plans and product requirements (features) with stakeholders (e.g., quality management, UX/UI, localization, regulatory teams)

• Working according to agile SW development methods with the software development team as their product owner (i.e., backlog management and creation of Epics/User Stories including detailed requirement specifications for product documentation)

• University degree in medical physics, computer science, engineering, business informatics, business information systems engineering, or a relevant adjacent subject; alternatively, a business degree and strong technology and healthcare experience

• Min 8 years of work experience and minimum of 5 years in agile software development of complex products, ideally in the health care or any other regulated industry at the interface of hard-and software or equivalent

• A proven track record of successfully launched and operated agile projects in the high-tech area

• Knowledge of agile product owner methodologies

• Strong problem solving and communication skills with the ability to exercise mature judgment

• Ideally experience from working in health care companies or comparable branches

• Fluent English skills

If you would like to know more about the role kindly contact the responsible recruiter: Sabrina Rieker (Write an email)

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