Hybrid Head of System Architecture – Release Management

at Fresenius Medical Care

• Job title: Head of System Architecture – Release Management
• Job type: Full Time
• Experience level: Lead
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Tech skills: TypeScript
• Location requirements: Hybrid, Schweinfurt, Germany

About the role

• Head of System Architecture & Release Management leading team for the 5008 family of dialysis products. Responsible for requirements management and project management with a focus on engineering quality.

Responsibilities

• Lead an interdisciplinary team responsible for product, system and software architecture, requirements management, holistic engineering and project management for the 5008 family.
• Provide technical and disciplinary leadership for a team developing, optimizing and maintaining dialysis devices including their software and components.
• Lead requirements engineering as well as product, system and software architecture: define and implement product requirements, hardware and software components and interfaces for the 5008 family.
• Own engineering project management: organize processes, workflows and activities, manage personnel, identify training needs and develop training plans.
• Plan, align, coordinate and monitor capacities and project budgets, taking into account priorities for the releases of the 5008 family.
• Build and develop a high-performing engineering team that independently drives development activities.
• Define, implement and adapt processes and workflows within the IC organization, including system configuration and variant management, risk management, device hazard analyses, interface management and project management.
• Demonstrate a fair and empathetic management style aligned with VSM’s strategic goals; act as an active role model.
• Mentor and develop team members with respect to performance, motivation and qualification.
• Promote a culture of continuous improvement and lean principles; take responsibility for the further development of processes and workflows within the team disciplines.
• Set the strategic direction of engineering for the 5008 family according to ISO/IEC/IEEE 15288:2015 (INCOSE) and using agile and traditional methods; coordinate with all involved disciplines, engineering houses and leaders of the 5008 family.

Requirements

• University degree (Diploma/Master) in natural sciences, business/economics or engineering, ideally in systems engineering, engineering, medical technology or a related field.
• Minimum of 5 years’ experience in the development of complex technical devices, preferably in medical technology or other safety-critical domains.
• At least 5 years’ project management experience in an R&D environment with knowledge of various methods (Waterfall, Agile, Lean, Design-to-Cost).
• Experience providing technical leadership to teams and stakeholders; preferably from automotive or medical technology sectors.
• Solid knowledge of regulatory requirements and processes in medical device development.
• Expertise in project management methods, capacity and budget planning, and R&D/engineering processes (risk and requirements management).
• Experience with architecture and ALM tools such as PTC Modeler, Enterprise Architect and preferably Polarion or Windchill.
• Practical experience in agile environments.
• Broad technical knowledge (actuators, sensors, HW/SW interfaces, hemodialysis products).
• Deep understanding of requirements management, risk management, system design, and product and system architecture — especially for safety-critical systems.
• Knowledge of relevant standards and norms (IEC 62304, IEC 60601, IEC 61508, ISO 26262, DO-178).
• Strong communication and stakeholder management skills.
• Very good German and English language skills.
• Willingness to travel occasionally nationally and internationally.

Benefits

• Health insurance
• Flexible working hours
• Professional development opportunities