Senior Systems Engineer
Role details
Job location
Tech stack
Job description
We are now looking for a Senior Systems Engineer to join our Brachy Solutions team in Veenendaal. In this role, you'll 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., * Lead the creation and maintenance of system requirements, system architecture, and R&D documentation for medical devices.
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Collaborate closely with product management, application specialists, service engineers, and other stakeholders to define user needs, customer requirements, and intended use.
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Translate requirements into functional and technical specifications.
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Design and maintain the system architecture, ensuring documentation is up to date and aligned with regulatory standards.
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Oversee the Design Dossier File (DDF) and ensure it reflects the current state of the product, including risk management.
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Act as a Subject Matter Expert (SME), coaching colleagues and supporting project execution and outsourced engineering activities.
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Serve as technical lead for product releases when needed.
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Conduct root cause analyses, write rationales, and propose improvements.
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Support cross-functional teams including Supply Chain Management, RA/QA, and customer-facing functions during audits, Post Market Surveillance reports, and complaint investigations.
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Lead feasibility studies and advise on new technologies for Brachytherapy.
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Contribute to the technology roadmap and promote knowledge sharing across Elekta.
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Stay informed on developments in medical technology and their potential applications.
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Act as Product Owner (PO) for scrum teams and coach on SAFe principles when required., In this role, you will work for a higher purpose; hope for everyone dealing with cancer, and for everyone regardless of where in the world, to have access to the best cancer care. You will be part of our international innovative team and given the opportunity to learn and develop.
Requirements
Do you have experience in Usability?, Do you have a Master's degree?, * Master's degree in embedded design, electronic engineering, systems engineering, mechatronic engineering, or a related field.
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Minimum of 5 years' experience in product development and design of mechatronic systems in a regulated industry, preferably medical devices.
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Strong background in risk management, requirements management, and subcontracting.
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Familiarity with MDR, IEC 60601, and other relevant standards.
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Experience with model-based design (e.g., Matlab/Simulink).
Personal Attributes:
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Fluent in English; Dutch proficiency is a plus or willingness to learn.
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Rational, pragmatic, and accurate.
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Strong analytical and problem-solving skills.
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Comfortable working in a structured and agile environment.
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Committed to quality and continuous improvement.
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Proactive, creative, and results driven.