Medical Device Systems Engineer (m/f/d)
Medical Device Systems Engineer (m/f/d)
- Vollzeit
Unternehmensbeschreibung
We are on an exciting journey where we are taking an active role in shaping the future of the digital healthcare ecosystem. You will be instrumental in shaping the way chronic diseases are treated by harnessing the latest technological advances. If you are fascinated by helping to shape the future of our drug delivery devices and service portfolio, and if you bring a fresh mind with new ideas on how we can offer patients a better quality of life, then we are excited to offer you a place where you will have the opportunity to creatively contribute to the future of healthcare.
As a listed company on the MDAX, Gerresheimer is a leading global partner for healthcare and cosmetics industries. We generate over 1.9 billion euros in sales and are represented worldwide with more around 11,000 employees.
Stellenbeschreibung
- Implement systems engineering approach to support the development and life cycle management of complex products and platforms in the areas of connected drug delivery devices
- Contribute to the development of complex medical devices using state-of-the-art system engineering practices. This highly interactive role will work with cross-function teams and support various development activities including requirement elicitation, system conceptualization, risk assessment, system verification and validation
- Guarantee a holistic approach to the development considering and balancing all aspects that concur to the success of the product: purpose, business needs, constrains, technical challenges, feasibility and trade-offs
- Guide the integration of software-controlled electro-mechanical systems starting from technology exploration, product definition and development, based on user needs and technical design input requirements
- Utilize the system engineering tool for requirements management and translate user and business needs into system/sub-system requirements.
- Participate in system design/review meetings to ensure appropriate integration and connectivity within overall system
- Define and maintain design history files, the traceability from the requirements to the verification activities and related deliverables
- Represent the system engineering team for the communications with cross-divisional teams, programs, and stakeholders within multi-cultural and international projects
- Collaborates with peers to identify opportunities for process improvement in a fast paced and growing organization
- Maintain up-to-date knowledge of medical devices, technologies and regulatory landscape relate to the company’s products
- Support of an experienced group of system engineers to support you and develop your skill as a systems engineer
Qualifikationen
- Bachelor or more advanced degrees in Systems Engineering, Electrical/Electronic Engineering, Computer Science, Biomedical Engineering or other relevant disciplines
- Relevant industry experience in a highly regulated environment is an advantage.
- Prior experience covering the medical device product development from concept to commercial launch, working with the requirements and traceability management tools is an advantage
- Strong analytical skills and ability to apply engineering principles using logical or scientific thinking to define and solve problems, collect data, establish facts, and draw valid conclusions
- Ability to cope with complexity of inter-disciplinary development team coordination
- Ability to capture and decompose customer needs into device and sub-systems requirements and engineering specifications. Document design input & output.
- Experience in systems design with good abstraction skills, system modeling, analyze problems and synthesize solutions
- Provide solid technical skill and engineering support for design, development, and troubleshooting activities
- Strong interpersonal and communication skills and ability to effectively work in a diverse, team driven environment
- Proficient use of Office applications like MS Outlook, Excel, Word, PowerPoint, Visio and Project
- Strong English written and verbal communication skills with both technical and non-technical users. Knowledge of German is an advantage
