Total 9 job vacancies by DE01 DEU Fresenius Medical Care D. GmbH

In this role you own the digital product, its digital journeys and the user experience. You will collaborate with prospective users and clients to understand and anticipate their needs and translate them into product requirements. This role can be filled Germany-wide.

Your assignments

• Works closely with Product Management and translates market trends and feature level requirements into executable work for agile teams
• Creates the product vision and roadmap which accomplishes the goal of the vision
• Manages the product backlog and priorities based on changing requirements
• Oversees all stages of product development process for medical and non-medical functionalities
• Coordinates cross-functional product teams and orchestrates priorities
• Monitors and evaluates product progress at each stage of the process
• Supports in developing market positioning for the product
• Ensures consideration of DSO (Digital Services & Operations) related activities, e.g. rollout, service, support

Your profile

• Master's degree in Business Administration, Computer Science, Data Science, Engineering or similar
• Minimum 5+ years experience in the healthcare sector, preferably as (senior) product management, program management or product owner
• Minimum 5+ years demonstrated track record of delivering digital solutions into healthcare organizations solving user-centric problems
• Work experience in clinic / hospital settings and / or digital health and innovation environments
• Good understanding of clinic processes as well as technological trends and impediments in Healthcare sector, preferably in the Nephrology domain
• Understanding of data formats, structuring and analysis is a plus
• Strong customer & user focus: Building strong customer relationships and delivering user-centric solutions
• In-depth knowledge of digital healthcare space, spanning from differentiated market segments to geographical variances

Senior Engineering Project Manager (m/f/d) nutzt seine umfassenden Erfahrungen zur Führung von F&E-Teams bei der Entwicklung von Medizinprodukten von der Konzeption bis zur Produkteinführung. Dies erfordert ein hohes Maß an funktionsübergreifender Koordination, ausgezeichnete schriftliche und mündliche Kommunikationsfähigkeiten sowie die Fähigkeit, gemeinsam mit allen wichtigen Stakeholdern Diskussionen zu führen und Entscheidungen zu treffen.

Ihre Aufgaben

• Verfügt über weitreichende Erfahrung und nutzt professionelle Konzepte zur Lösung kritischer Probleme und umfassender Designfragen
• Als fachlicher Experte leitet er komplexe F&E-Projekte in der gesamten Planungs-, Implementierungsphase bis zur Produktionsreife und erbringt Supportleistungen
• Erstellt, optimiert und steuert strukturierte Zeit- und Projektpläne. Legt Termine fest, hält sie ein bei qualitativ hochwertigen Ergebnissen bei effektiver Anpassung und Änderung von Plänen auf Grundlage von sich ändernden Bedingungen oder Daten
• Arbeitet an komplexen Fragestellungen, bei denen die Analyse von Situationen oder Daten eine eingehende Evaluierung variabler Faktoren erfordert. Beurteilt die Auswahl von Methoden, Techniken und Bewertungskriterien zur Erreichung von Ergebnissen
• Bestimmt Methoden und Vorgehensweisen bei neuen Aufgaben und koordiniert ggf.  Aktivitäten anderer Mitarbeiter (Team Lead).  Unterhält Netzwerke mit wichtigen Kontakten außerhalb seines Fachgebiets
• Zusammenarbeit über alle Funktionsbereiche hinweg (F&E, Marketing, QS/QK, Regulatory, Clinical, Operations, Service und andere) soweit notwendig zur Sicherstellung von Projektabschluss und –ergebnis
• Antizipiert, identifiziert, dokumentiert und managt wichtiger Programmrisiken; schlägt geeignete Risikominimierungs- und Notfallpläne vor und forciert sie.
• Vorbereitung von Projekt-Dashboards und klare Kommunikation des Fortschritts über organisatorische Grenzen und Ebenen hinweg, vom einzelnen Mitarbeiter bis zum leitenden Angestellten
• Planung der Ressourcenanforderungen und Aushandlung der Kernteam-Ressourcen mit F&E-Funktionsmanagern
• Führt Teams bei der Festlegung und Priorisierung von Umfang, Zielen und Anforderungen.
• Baut effektive Beziehungen zu Kernteammitgliedern und erweitertem Mitarbeiterteam, zu Funktionsmanagern, Führungskräften und Kunden auf
• Überprüfung und Befolgung des Verhaltenskodexes und aller geltenden Unternehmensrichtlinien und –verfahren sowie lokaler, staatlicher und bundesstaatlicher Gesetze und Vorschriften

Ihre Qualifikation

• Bachelor- oder Masterabschluss in einem technischen und / oder betriebswirtschaftlichen Bereich (d.h. Elektrotechnik, Maschinenbau, Physik, BWL, o.ä.)
• Mindestens 8 + Jahre Erfahrung in der Produktentwicklung und/oder im Projektmanagement, vorzugsweise in der Medizinprodukteindustrie
• Minimum 4 Jahre Erfahrung als Software-Projektmanager  
• Praxiserfahrung in der Führung von crossfunktionalen Teams
• Erfahrung mit dem gesamten Development Life Cycle vom Konzept bis zum Ende des Produktzyklusses
• Kenntnisse mit dem Projektmanagement für Softwareentwicklungsmethoden sowohl für traditionelle (lineare) und die schnelle (iterative) Anwendungsentwicklung
• Erfahrung in der Entwicklung lebenskritischer Software in einem regulierten Umfeld, idealerweise Medizinprodukte-Umfeld
• Erfahrungen mit dem Eingehen von Kompromissen und Entscheidungsfindungen beim Projektmanagement
• Kenntnisse mit dem Produktrisiko-Management, idealerweise in einem regulierten Umfeld
• Experte im Umgang mit Projektmanagement-Tools, Kollaborations-Tools
• Know-How im Umgang mit Produkt LifeCycle Tools (PLM) und Application Lifecycle-Management-Tools (ALM) Produktdaten-Management-Tools (PDM) und Task Management-Tools (z.B. Azure Devops)
• Fließende Deutsch- und Englischkenntnisse in Wort und Schrift
• Bereitschaft zu gelegentlichen Dienstreisen im In- und Ausland

Your task:

• Being the main contact person for the product multiFiltratePro for the Sustaining Engineering Interfaces in the global market
• Secure continuous production process in close collaboration with all relevant stakeholders and a high level of product quality
• Ensure product availability regarding field issues and regulatory changes
• Define and coordinate design changes with appropriate prioritization often under unplanned, time-sensitive and cross-vertical conditions
• Being the center of excellence for technical questions in the market
• Coordinate the Sustaining backlog to ensure the transparency of maintenance needs
• Realization of the work packages in cooperation with Engineering Unit and Agile Framework
• Active membership in the PI-Planning representing the Sustaining Engineering Unit
• Proactively analyze high level machine data to mitigate quality issues
• Sustaining representative for multiFiltratePro in different meetings and committees 

Your profile:

• Completed technical studies in medical engineering, electrical and mechatronic engineering or comparable education with at least 5 years of professional experience 
• Several years of professional experience in medical technology and R&D
• Ownership is your passion – together with your partners you are driving results and success
• Being an excellent networker to be connected to the stakeholders for best communication and collaboration  
• You will be able to run many themes at once and coordinate complex organizational and technical topics efficiently 
• You are ready to take the driver's seat and bring about competent decisions 
• You are willing to work in partnership with partners all over the world  

Our offer to you

There is a lot for you to discover at Fresenius, because we have a lot to offer. No matter in which field you are an expert (m/f/d) and how much experience you bring with you - for your professional future with meaning:

• The opportunity to work on a mobile basis
• Whether in front of or behind the scenes - you will help to make better and better medicine available to more and more people around the world
• Individual opportunities for self-determined career planning and professional development
• A corporate culture in which there is enough room for innovative thinking - to find the best, not the fastest, solution together
• A large number of committed people with a wide range of skills, talents and experience
• The benefits of a successful global corporation with the collegial culture of a medium-sized company

Please note that in addition to your CV, please also submit your references and certificates and, ideally, a cover letter before completing your application.

We are seeking a talented and experienced Senior Expert Requirements Engineering - Digital Ecosystem (m/f/d) to join our team. In this role, you will take end-to-end responsibility to drive the success of our industry-leading medical product portfolio. Fresenius Medical Care is dedicated to creating a future worth living for patients, worldwide, every day. In Value Stream Digital Products, we are working cross-functionally to bring innovative high-quality digital products and enablers to our global customers, drive growth and business success. You can expect an agile working environment focused on outcome, and a collaborative and proactive mindset. 

Your assignments

• Define, set-up, maintain and manage the complex product requirements for digital ecosystem / products.
• Team take the responsibility for correct common understanding of requirements to be implemented
• Working with PMs/POs of ecosystem fields of actions to gain understanding of topics, environment / context, stakeholder needs, clinic process
• Translate stakeholder need / business requirements into 1st level of system requirements (problem space, technical level) and further breakdown into official deliverables of GPDP (SysRD, URD, PRD) according to FMC SE methodology and guideline
• Ensure the traceability for the requirements implemented
• Responsible for review of requirements and fulfilling the acceptance criteria
• Responsible for the requirements change management
• Support the document creation user requirements, service manuals and instructions for use
• Structure and gather existing stakeholder needs into one concise In-Center Digital Ecosystem Stakeholder Needs list comprising of all ecosystem fields of actions
• Support breakdown of these stakeholder needs per focus topic and elicitation into 1st level of system / product requirements

Your profile

• Successfully completed studies of electrical engineering, computer science or similar
• More than 5 years of professional experiences in Requirements Engineering, Product Management or Product Ownership (“expert”)
• Experience in product development of medical devices
• Functional leadership experience
• Experience in the development of technical systems (component / hardware / software development) in the following areas automotive, aerospace or medical technology as well as in functional safety
• Knowledge of relevant standards such as IEC62304, IEC60601, IEC61508, ISO26262, DO-178
• Experience in an agile environment e.g. SCRUM
• Experience in handling requirements management tools such as Polarion, DOORS, WindChill and MS Office
• Strong communication and organizational skills
• Fluent in English and German, in written and spoken

In your role as Regulatory Affairs Manager (m/f/d) you will support product registrations, provide design input and assess changes to ensure regulatory product availability on global markets.

Your assignments:

• Obtain and sustain global registrations for product portfolio as per Regulatory Strategy and product roadmap
• Provide Regulatory Strategy and product roadmap input as primary liaison to local and global product teams
• Compile global registration file (STED) per product and customize/ supplement in preparation of local submission where necessary
• Communicate / collaborate with relevant global interfaces
• Support site registrations and tender procedures
• Provide regulatory design input and submission strategy guidance to sustaining and development project teams to ensure creation of approval-relevant documents

Your profile:

• Completed studies in a scientific/technical field or comparable training with professional experience
• Several years of experience in the field of Regulatory Affairs, preferably for medical devices in global markets
• Business proficient in English (written and spoken)

We are seeking a talented and experienced Systems Architect Digital Ecosystem (m/f/d) to join our team. In this role, you will take end-to-end responsibility to drive the success of our industry-leading medical product portfolio. Fresenius Medical Care is dedicated to creating a future worth living for patients, worldwide, every day. In Value Stream Digital Products, we are working cross-functionally to bring innovative high-quality digital products and enablers to our global customers, drive growth and business success. You can expect an agile working environment focused on outcome, and a collaborative and proactive mindset. 

Your assignments

• Designing complex systems and systems of systems within the In-Center Ecosystem
• Technical leadership role to drive and document requirements, architecture and design solutions of the respective sub-system/component across different trades (e.g. electrical, mechanical, digital)
• Working with PMs/POs of ecosystem fields of actions to gain understanding of topics, environment / context, stakeholder needs, clinic process
• Propose and evaluate architectures with product managers / POs and architects of HD devices, water tech, digital products to find best architectural direction
• Elaborate on the need of an edge device
• Zig-zagging between needs / requests and architecture: align technical requirements and architecture with Product and Platform Architects
• Preparation and maintenance of architectural documentation, taking risk-reducing measures into account
• Responsible for the generation of a modular architecture that would drive detailed engineering development work across different engineering trades, i.e. electrical, mechanical, digital etc
• Perform functional allocation from functional architecture to physical architecture
• Responsible for ensuring delivery and the integration capability of the respective system into the overall ecosystem
• Model system / product architecture in professional format (e.g. UML/SysML in Modeler)

Your profile

• Master’s degree or higher in Electrical/Electronic/Computer Engineering preferred
• More than 5 years of experience as systems architect (“expert” in system architecture”)
• Experienced product owner for digital tools and/or embedded software
• Some years of Systems Engineering experience in aerospace and/or automotive industry helpful
• Several years of functional leadership experience (especially with global cross-functional teams) 
• Ability to break down high-level architecture for core engineering functions (electrical, mechanical, software)
• Experience conducting trade-off analysis to establish optimal level of scalability and flexibility of modules in a functional architecture
• Experienced in Requirements Management for software/hardware, including interface requirements across lower level (mechatronic) modules
• Profound system knowledge of medical devices (i.e. dialysis machines) or complex mechatronic systems preferred
• Experience with requirements management tools (e.g. Polarion, DOORS, WindChill etc.)
• Driving personality and ability to make high-quality decisions
• Strong communication, presentation and influencing skills across all levels and roles in a large organization
• Fluent in English and German, in written and spoken

In your role as Head of Supply Chain Excellence (m/f/d) your main focus will be driving and sustaining end to end Supply Chain improvement in process and technology to enhance asset utilization, cost optimization and service level; leading the effort to develop and implement global strategic initiatives across Fresenius Medical Care with targeted scope and defined outcome; and developing SC Excellence team to drive culture and mindset change throughout the supply chain organization.

Your Assignments

• Improve existing processes based on best in practice standards and ensure structured training and roll-out to realize efficiency gains across the whole Value Chain
• Identify improvement opportunities across end-to-end supply chain functions globally based on in-depth knowledge of current processes obtained through continuous learning and structured analytical approach
• Evaluate, propose, and implement fit-for-purpose Supply Chain system/technology to advance process automation where possible with support from subject matter experts
• Strengthen cross-function collaboration to drive implementation of improvement initiatives globally through defined work packages with aligned milestones and timelines.  Establish effective reporting and performance measurement of installed initiatives and strive for continuous improvement
• Ensure governance structure for integrated processes and (master) data management
• Establish, manage, and lead a high-performing team of analysts and process experts
• Build and foster technical / analytical skill set required to carry out varied analytical tasks
• Manage overall timeline, milestones, and targets to build relationships, secure support and resources for projects
• Create and implement training program to expand knowledge, skills, and competencies for employee personal career development aligned with organizational change and growth objective
• Sustain change in behavior and mindset to harness benefits created from projects and programs into long term organization best-in-practice worldwide

Your Profile

• Successfully completed master’s degree in industrial engineering, supply chain management or business administration
• APICS certification preferred, e.g., Certified Supply Chain Professional (CSCP), Certified in Production and Inventory Management (CPIM)
• Extensive work experience in Supply Chain Excellence/Transformation, or similar functions within Finance, Manufacturing in a complex global manufacturing organization, including minimum two years of people management
• Demonstrated experiences in applying process improvement methodology (lean or similar) and analytics to drive change management/organizational development, program development and project management
• Experience with budgeting and financial planning models in a multi-national company is a plus
• Consulting background in supply chain management with proven track record on successful implementation of improvement/transformation is a plus
• Well organized and systematic in work processes, possess excellent communication and collaboration skills and has ability to multi-task and handle multiple priorities while managing deadlines
• Demonstrated ability to understand and breakdown complex and complicated situations and problems
• An adaptive leader to effectively manage team with diverse academic, cultural and professional background
• Fluent in English and German, both in written and spoken

In your role as Senior Project Manager Supply Chain Management (m/f/d) you will be responsible for providing comprehensive planning, execution, and overall leadership of multiple medium to large-scale initiatives designed to drive and sustain end to end Supply Chain process improvement.

Your Assignments

• Develop and deliver progress reports, proposals, requirements documentation and presentation to various audience, including project team, sponsors and key stakeholders
• Manage complex projects that span multiple lines of business mainly in the area of process improvement, e.g. demand and supply planning, distribution and transportation, quality release etc
• Set and continuously manage project expectations while delegating and managing deliverables across various team/business units and stakeholders
• Act as a subject matter expert in Project Management, Process Improvement and Strategy Planning
• Guide and collaborate with Supply Chain Excellence team to drive process improvement installing best practices, templates, policies, and tools etc
• Work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Exercise judgement in selecting methods, techniques, and evaluation criteria for obtaining results
• Research best practices within and outside the organization to establish benchmark data and use continuous process improvement disciplines to achieve results
• Build and maintain relationships by engaging business leaders to establish credibility, solve problems, build consensus, and achieve objectives
• Mentor other staff as applicable

Your Profile

• Successfully completed bachelor’s or master’s degree in field of supply chain management (SCM), engineering, economics or equivalent
• Experiences and / or in-depth knowledge of SCM is a must
• APICS certification / experience in Inventory Management is a strong plus
• Lean Six Sigma is an advantage
• More than 5 years extensive project management experience in a similar role, within a cross-functional matrix environment in a global organization
• Demonstrated track record of successfully delivering projects within defined timeline and budget
• Proven ability to demonstrate a drive for results and accountability of business needs
• Willingness to work in an evolving environment and collaborate across multiple business areas to achieve common business objectives
• Technologically savvy with new tools / features within SCM landscape
• Strong communication and time management skills
• Fluent in English both in written and spoken, German language is a plus

This role combines the Design Quality Assurance and the Product Center Manager role. In your role as Design Quality Assurance Expert (m/f/d) you will be working as a part of product development team on new product development or on design changes to ensure product quality and reliability, minimize risk to users and patients. In addition, the Product Center Manager's responsibilities are added to this position, which includes post-market surveillance tasks and ensuring regulatory compliance. This ensures that the entire life cycle of the product can be managed and controlled.

Your assignments

Design Control

• Ensure that all design control deliverables comply with applicable regulatory requirements and design control processes
• Guide engineering and other teams and ensure that design control requirements are being met in an effective manner to achieve quality by design, including those for design verification, validation, specification and procedure development, risk management, and design review
• Provide input to design and manufacturing engineering project DHF deliverables including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured and tested. Review DHF files for accuracy and completeness and provide guidance on FDA compliance and procedures
• Work independently on high visibility new product development projects; including projects involving multiple technologies and design sites
• Create processes and process improvements to ensure consistent implementation of internal requirements and external regulations and standards

Product Conformity

• Main contact for medical devices marked with the CE-mark with a focus on non-active medical devices for Peritoneal Dialysis
• Ensure that Technical Files are complete and up to date and that essential requirements are met

Post Market Surveillance

• Analyze PMS data and if needed initiate required activities

NC/CAPA

• Acts as a Quality Approver for design control related topics and as a Quality Assignee for system related topics

Your profile

• Bachelor or master’s degree in engineering or a similar technical field required, such as medical technology or a technical apprenticeship with further training to be a technician, along with relevant professional experience
• Several years related experience or an advanced degree without experience
• Advanced knowledge of Design Control and Risk Management standards (e.g, ISO13485, IEC 60601 and ISO 14971)
• Advanced knowledge of medical device regulations (e.g. MDR 745/2017, 21CFR820.30, NMPA-Regulation)
• Experience with product or design and development or quality engineering of sterile disposables utilizing various plastic processes such as injection molding and extruding
• Deep understanding of Design Controls and solid engineering expertise that enables them to guide engineering teams
• Experienced with development of design input and traceability through verification and validation V&V activities
• Excellent presentation and communication skills, high engagement on achieving targets and ability to communicate technical information to non-technical audiences
• Willingness to travel national and international
• Fluent in written and spoken English and German