IT - System Engineer designing tailored IT solutions while ensuring infrastructure security and performance. Join a dynamic team at wunderbar IT GmbH focusing on innovative technologies for B2B clients.
About the role
- System Engineer responsible for medical software design and lifecycle management in surgical products. Collaborating with international teams to ensure high-quality regulatory compliance.
Responsibilities
- Prepare and lead product design phases with the Product Owner, development team and Quality department.
- Participate in the creation and maintenance of design documentation throughout the medical device lifecycle.
- Contribute to risk management, product safety and device usability together with the project team and the Quality department.
- Take part in design reviews as well as verification and validation phases, ensuring performance, quality and regulatory compliance objectives are met.
- Establish working relationships with stakeholders to successfully meet software delivery deadlines that align with customer expectations and to support regulatory submissions.
- Collaborate with Clinical, Legal, Commercial and Post-market Surveillance teams.
- Contribute to quality activities (non-conformities (NC), CAPA and complaints) and lead corrective action plans when required.
- Participate in audits and inspections to respond to questions regarding design and product development.
Requirements
- Engineering degree or Master’s in biomedical engineering, computer science or a related discipline.
- Minimum 2 years of professional experience in a systems integration and/or V&V engineer role.
- Strong English language skills required.
- Knowledge of agile software principles and the software development lifecycle, ideally within a regulated environment.
- Knowledge of medical device regulations: ISO 13485, ISO 14971, EN 62304, 21 CFR 820 (FDA).
- Experience formalizing customer specifications to define a validation strategy.
- Experience contributing to a design dossier for software or a medical instrument is a plus.
- Experience in medical software validation is a plus.
- Attention to detail, strong writing skills, rigor and effective time management.
Benefits
- Career development: Opportunities for vertical and horizontal progression supported by ongoing training programs to develop your skills and expertise.
- Great Place to Work: Work for the 8th best company in the "Great Place to Work" ranking.
- Work environment: A collaborative R&D environment that promotes the use of agile methodologies, ensuring efficiency and innovation throughout the development cycle.
- Global impact: Join a team whose solutions are transforming surgical procedures and improving patient outcomes worldwide.
- Competitive compensation: An attractive salary and benefits package, including health insurance, a retirement plan and performance-based bonuses.
- Innovation culture: Be part of a company where creativity and new ideas are encouraged to meet clinical needs and shape the future of healthcare.
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