Du treibst die Entwicklung medizinischer Geräte voran und führst Risikobewertungen durch, um ein sicheres Design zu gewährleisten und interne Prozesse zu verbessern.
Anforderungen
- •Master's degree in relevant field
- •Experience in medical device systems design
- •Technical background in Cardiopulmonary field
- •Requirements engineering knowledge
- •Optional: Medical Devices risk management
- •Fluency in English, written and spoken
- •German language skills at least level B2
- •Analytical and problem-solving abilities
- •Ability to present ideas to different audiences
- •Systematic task segmentation and execution
- •Strong moderation and coordination skills
- •Knowledge of Model-Based Systems Engineering tools
Deine Aufgaben
- •Entwicklung und Verbesserung medizinischer Geräte vorantreiben
- •Komplexe Systeme in Teilsysteme zerlegen
- •Systems Engineering-Kenntnisse anwenden
- •Risikobewertungen auf System- und Teilsystemebene durchführen
- •Auswirkungen und Schwere potenzieller Anomalien bewerten
- •Vollständige und harmonisierte Designanforderungen ableiten
- •Funktionale Charakterisierung des Systems durchführen
- •Notwendiges klinisches Wissen aufbauen und dokumentieren
- •Interne Prozesse kontinuierlich verbessern
Deine Vorteile
Dynamische Rolle im Medizintechnikbereich
Zugang zu modernen Entwicklungsprozessen
Wettbewerbsfähiges Grundgehalt
Variable Anreize kurz- und langfristig
Anerkennung durch das STARS-Programm
Original Beschreibung
# Systems Engineer (m/f/d)
**Munich, Germany** | **Full time**
**Systems Engineer (m/f/d)**
**Position Summary**
The Systems Engineer takes responsibility for defining system and subsystem level design inputs, architecture views, and interfaces as well as for risk and anomaly management for new product development projects and the lifecycle of the existing portfolio. The role interfaces strongly with cross-functional teams, such as other R&D engineering disciplines, project management, strategic marketing, operations, service, quality, and regulatory affairs. The Systems Engineer provides system level expertise on concepts and solutions that meet the needs of users and other stakeholders to facilitate a successful market introduction and lifecycle of our cardiopulmonary portfolio.
**General Responsibilities**
* Drive development and improvement of medical devices in the Cardiopulmonary field by owning and managing system level requirements
* Decomposing complex systems into subsystems with defined interfaces and detailed behavior, enabling technical disciplines to seamlessly cooperate on the design
* Applying Systems Engineering know-how to generate stakeholder-tailored views of functional, logical, and physical architecture
* Plan and execute Risk Assessments of system and subsystem levels to derive a state-of-the art safety architecture and risk mitigation measures, in cross-functional teams
* Assess impact and severity of potential anomalies to support timely issue resolution
* Derive complete and harmonized design input requirements on system and subsystem level
* Functional characterization of the respective system in terms of clinical procedures and derived system behaviors
* Build, document and maintain necessary clinical knowhow
* Cooperative composition and continuous improvement of internal processes
**Skills and Experience**
* Master's degree in medical technology, engineering, science or comparable level of education
* Experience in systems design and development preferentially in medical device area
* Technical background from an engineering discipline or clinical background in the Cardiopulmonary field
* Requirements engineering would be a plus
* Optional: Risk management of Medical Devices
* Fluency in English, written and spoken; preferred: German language skills at least level B2 or higher
* Analytical, conceptual and problem-solving abilities
* Ability to present ideas and concepts tailored to different target audiences
* Ability to systematically segment, prioritize and execute tasks
* Strong, open-minded and transparent ability to moderate and coordinate stakeholders across different functions to create consensus
* Preferred: Tool/process knowledge for Model-Based Systems Engineering and Requirements Management, like Polarion ALM, Sparx Enterprise Architect
* Occasional travel may be required
**What we can offer you**
In addition to providing you with a supportive, inclusive and collaborative environment where you will feel empowered to take ownership and drive meaningful change, we will reward you with the following:
* A dynamic role in an advanced Medical Device environment interfacing with all worldwide regulatory landscapes supporting your professional career growth
* Exposure to a *State-of-the-Art* medical device development process, in close co-operation with international clinicians
* Competitive base salary
* Variable short-term & long-term incentives
* Recognition: through our STARS Program, we recognize and celebrate our colleagues’ contributions and achievements
**Our commitment to Diversity & Inclusion:**
*LivaNova values equality and celebrates diversity. We are committed to ensuring that our recruitment process is fair, transparent and free from unlawful discrimination.*
*Our selection process is driven by the key demands/requirements for the role rather than bias or discrimination on the basis of a candidate’s sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification.*
**Notice to third party agencies:**
*Please note that we do not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Services Agreement, we will not consider, or agree to, payment of any referral compensation or recruiter fee. In the event that a recruiter or agency submits a resume or candidate without a previously signed agreement, we explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.*
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