System Designer

We are seeking a
System Designer
to lead assigned system design activities within New Product Introduction (NPI) projects for computer-assisted surgical and robotic systems. In this role, you will own technical deliverables across system requirements, design inputs, architecture support, risk management, verification and validation, usability engineering, design changes, and Design History File (DHF) documentation.You will work independently to drive product features, subsystems, or projects forward, while taking part in hands‑on robotic testing and integration activities and collaborating closely with multidisciplinary project teams.Work Mode:
Hybrid (minimum three days per week in office)Travel:
Up to 25% is requiredKey Responsibilities
Lead assigned system design activities within NPI projects for computer‑assisted surgical and robotic systemsDefine and maintain system requirements and design inputs, ensuring they are clear, testable, and traceableSupport system architecture development and decisionsDraft and maintain DHF content, including user needs, system requirements, design inputs, traceability matrices, and risk documentationSupport risk management activities, including risk analysis (e.G., uFMEA), and contribute to design mitigationsContribute to usability planning and usability engineering activitiesSupport the development of verification and validation (V&V) protocols in collaboration with the Product Development teamManage and document design changes in accordance with applicable proceduresParticipate in hands‑on robotic testing and integration activitiesIndependently drive technical deliverables for assigned product features, subsystems, or projectsCollaborate with R&D, QA, clinical, and regulatory teams, translating technical information clearly for diverse stakeholdersEngage effectively with both internal and external collaboratorsQualifications
Bachelor’s degree in engineering, science, or a related technical field (e.G., biomedical, computer, mechanical, or electrical engineering)A degree in biomedical engineering is an asset5+ years of experience in system design
within a multidisciplinary organizationExperience working in a regulatory environment with strict compliance requirementsExperience drafting and maintaining DHF content, including user needs, system requirements, design inputs, traceability matrices, and risk documentationExperience with Codebeamer, Windchill, and/or JIRA, or similar toolsKnowledge and Skills
Familiarity with ISO 14971 (required)Familiarity with IEC 62366 (preferred)Ability to support risk analysis (e.G., uFMEA) and contribute to usability planning and design mitigationsAbility to define testable requirements, support V&V protocol development, and ensure traceabilityStrong analytical skills and sound judgmentExcellent written and verbal communication skillsStrong collaboration skills across R&D, QA, clinical, and regulatory functionsAbility to deal effectively with internal and external collaboratorsWhy choose us
An international community bringing together more than 110 different nationalitiesAn environment where trust is central: 70% of our leaders started their careers at the entry levelA strong training system with our internal Academy and more than 250 modules availableA dynamic work environment that frequently comes together for internal events (afterworks, team buildings, etc.)Amaris Consulting promotes equal opportunities. We are committed to bringing together people from diverse backgrounds and creating an inclusive work environment. In this regard, we welcome applications from all qualified individuals, regardless of sex, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.
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