Key Skills

Job Description

About This Vacancy Are you an experienced engineer with a passion for product safety, risk management, and continuous quality improvement within the medical device industry? Do you want to play a key role in ensuring the safety and reliability of advanced image-guided therapy systems used during life-saving procedures worldwide? We are looking for a Senior Product Safety & Risk Management Engineer to join our Image Guided Therapy (IGT) organization. In this role, you will be responsible for leading product safety and risk management activities for our Azurion and Allura platforms throughout their entire lifecycle, from new product introductions to post-market surveillance and sustaining engineering activities. You will collaborate closely with multidisciplinary teams across R&D, Quality, Regulatory Affairs, Service, Medical Affairs, and Post-Market Surveillance to ensure patient safety remains at the center of every decision. Your Responsibilities As a Senior Product Safety & Risk Management Engineer, you will: Lead and execute product safety and risk management activities across the full product lifecycle, including New Product Introduction (NPI), sustaining engineering, and post-market surveillance. Own and drive risk management deliverables, ensuring compliance, completeness, quality, and timely execution. Act as CAPA Owner when required, managing corrective and preventive action processes from investigation through implementation, effectiveness verification, and closure. Author, review, and approve risk assessments, safety evaluations, safety rationales, and risk management documentation supporting investigations, field actions, and product decisions. Define hazardous situations, assess potential harms, and evaluate associated risks in accordance with ISO 14971 and internal quality requirements. Support root cause investigations through structured problem-solving methodologies such as FMEA, Fault Tree Analysis (FTA), Fishbone Analysis, and 5-Whys. Analyze complaint trends, system logs, installed-base data, field performance information, and replacement rates to generate risk-based insights and recommendations. Collaborate with cross-functional stakeholders to define, implement, and monitor corrective and preventive actions from a product safety perspective. Ensure global consistency and compliance of risk management practices, processes, templates, and documentation. Provide clear reporting on safety-related activities, risks, trends, and performance metrics to leadership and governance teams. Support audits, inspections, and regulatory assessments by ensuring documentation is complete, accurate, and audit-ready. Coach and mentor engineers, authors, and reviewers in risk management best practices and methodologies. Contribute to the continuous improvement of product safety processes and organizational capabilities. What We Expect From You Education Master's degree in Mechanical Engineering, Electrical Engineering, Systems Engineering, Software Engineering, Biomedical Engineering, or a related technical discipline. PhD or advanced specialization in safety engineering, reliability engineering, or risk management is considered an advantage. Experience Minimum of 5 years of experience in product safety, risk management, systems engineering, or quality engineering within a regulated medical device environment. Demonstrated experience with CAPA processes, complaint investigations, field actions, and post-market surveillance activities. Proven track record of driving complex cross-functional initiatives to successful completion. Experience supporting audits and inspections by regulatory authorities or notified bodies is preferred. Knowledge & Skills Strong knowledge of: ISO 14971 ISO 13485 IEC 62366 FDA QSR/QMSR requirements Medical device product lifecycle processes Experience with risk assessment and risk control activities for complex multidisciplinary systems. Strong analytical and problem-solving capabilities. Experience applying methodologies such as: Failure Mode and Effects Analysis (FMEA) Fault Tree Analysis (FTA) 5-Whys Fishbone Analysis Ability to translate data into meaningful safety and business insights. Excellent technical writing and documentation skills. Strong communication, stakeholder management, and influencing skills in an international environment. What You Can Expect From Us An opportunity to directly impact patient safety and healthcare outcomes worldwide. A highly visible role within a leading medical technology organization. Collaboration with international multidisciplinary teams. Exposure to cutting-edge image-guided therapy technologies. Opportunities for professional growth, leadership development, and technical specialization. A culture focused on innovation, quality, and continuous improvement.

Core Responsibilities

Lead product safety and risk management across the full lifecycle of the Azurion and Allura platforms, including new product introduction, sustaining engineering, and post-market surveillance. Own risk documentation and CAPA activities, analyze safety and field-performance data, support investigations and audits, and guide cross-functional teams in improving safety processes.

Requirements

Requires a master's degree in a relevant engineering discipline and at least five years of experience in product safety, risk management, systems engineering, or quality engineering in a regulated medical device environment. Candidates should have experience with CAPA, complaint investigations, field actions, and post-market surveillance, plus knowledge of applicable medical-device standards and risk-analysis methods.

Benefits

• Professional Growth Opportunities
• Leadership Development
• Technical Specialization