We are looking for a Senior Systems Engineer to join our Brachy Solutions team in Veenendaal. As a Senior Systems Engineer, you will take the technical lead in defining and maintaining system requirements and architecture for our medical devices, ensuring they meet the highest standards of safety, usability, and performance.
Requirements
- Lead the creation and maintenance of system requirements, system architecture, and R&D documentation for medical devices.
- Collaborate closely with product management, application specialists, service engineers, and other stakeholders to define user needs, customer requirements, and intended use.
- Translate requirements into functional and technical specifications.
- Design and maintain the system architecture, ensuring documentation is up to date and aligned with regulatory standards.
- Oversee the Design Dossier File (DDF) and ensure it reflects the current state of the product, including risk management.
- Act as a Subject Matter Expert (SME), coaching colleagues and supporting project execution and outsourced engineering activities.
- Serve as technical lead for product releases when needed.
- Conduct root cause analyses, write rationales, and propose improvements.
- Support cross-functional teams including Supply Chain Management, RA/QA, and customer-facing functions during audits, Post Market Surveillance reports, and complaint investigations.
- Lead feasibility studies and advise on new technologies for Brachytherapy.
- Contribute to the technology roadmap and promote knowledge sharing across Elekta.
- Stay informed on developments in medical technology and their potential applications.
- Act as Product Owner (PO) for scrum teams and coach on SAFe principles when required.
Benefits
- 27 paid vacation days per year plus 13 ATV days
- Global bonus plan or Profit scheme
- Travel allowance
- Good pension fund Metalektro, 50/50 payment
- Insurance discounts
- Active staff association
- Tax benefits for fitness centres and bicycle purchases
- Hybrid work option (you are required to work on location at least 3 days/week)