Head of System Architecture – Release Management
Fresenius Medical Care
full-time
Posted on:
Location Type: Hybrid
Location: Schweinfurt • 🇩🇪 Germany
Visit company websiteJob Level
Lead
Tech Stack
TypeScript
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
requirements engineeringproject managementrisk managementsystem designproduct architecturesoftware architecturecapacity planningbudget planningagile methodologiesLean principles
Soft skills
technical leadershipmentoringcommunicationstakeholder managementteam developmentorganizational skillsempathetic managementcontinuous improvementperformance motivationrole modeling
Certifications
ISO/IEC/IEEE 15288:2015IEC 62304IEC 60601IEC 61508ISO 26262DO-178