Medical Device Systems Engineer

• 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

Requirements

• 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