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# Senior Systems Engineer Consultant

- **Company:** Amaris
- **Location:** AMSTERDAM, Netherlands
- **Experience:** Expert
- **Contract:** Permanent contract
- **Skills:** Systems Engineering, Failure Mode Effects Analysis
- **Published:** October 14, 2026
- **Apply:** https://www.indeed.com/viewjob?jk=54727912f95046fc

## About the Role

* Master's degree in Mechanical, Electrical, Software, Systems Engineering, or a related discipline; a PhD is a plus.
 * 5+ years of experience in systems engineering, product safety, risk management, or a related role within the regulated medical-device sector.
 * Strong knowledge of ISO 14971, ISO 13485, IEC 62366, FDA QSR/QMSR, and post-market surveillance requirements.
 * Experience supporting CAPA investigations, field actions, complaint reviews, and product-safety assessments.
 * Hands-on knowledge of structured problem-solving methods, including FMEA, FTA, 5 Whys, Fishbone analysis, and root-cause investigation.
 * Ability to analyse complex, multidisciplinary systems and understand dependencies between hardware, software, users, and clinical workflows.
 * Experience using complaint data, system logs, installed-base data, replacement rates, and other operational information to support risk-based decisions.
 * Strong project-management skills, with a record of delivering complex technical and compliance-related activities through to closure.
 * Excellent technical writing skills, with experience producing clear risk assessments, safety rationales, investigation reports, procedures, and audit-ready documentation.
 * Familiarity with CAPA, change-control, risk-management, and quality-management systems, plus experience supporting audits by regulatory authorities or notified bodies.

## Description

* Lead product safety and risk management activities across the full product lifecycle, from new product introduction through sustaining engineering and post-market surveillance.
 * Own safety-risk deliverables from initial assessment to approval and closure, balancing technical quality, regulatory compliance, audit readiness, and deadlines.
 * Drive CAPA investigations by defining hazardous situations, linking failure modes to potential harm, assessing severity and occurrence, and documenting root causes.
 * Author and review post-market risk reviews, safety rationales, risk assessments, and supporting records for investigations, field actions, and complaint-trending decisions.
 * Translate complaint data, system logs, installed-base information, and replacement rates into clear risk assessments and recommended actions.
 * Coordinate corrective and preventive actions with R&D, Quality, Service, Regulatory, Medical, and Post-Market Surveillance teams.
 * Monitor action plans, implementation risks, effectiveness checks, and closure activities, escalating issues when delivery or safety may be affected.
 * Produce status reports, trend analyses, and performance metrics for management and governance forums, while coaching authors, reviewers, and engineering teams on risk-management practices.