Engineering & Science - Safety Engineer
- 🇨🇳 China
- On-site
- 1 day ago
- Risk Management
- IEC
- FMEA
- Regulatory Compliance
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Elekta is shaping the standard of care, together with healthcare providers, by developing precision radiation medicine that brings advanced radiotherapy into routine clinical practice. Our solutions support consistent, efficient and personalized care, addressing evolving patient needs. Through adaptive radiotherapy, precision treatment delivery and integrated workflows, Elekta supports care teams across a range of clinical settings. Each year more than 2 million patients are treated using Elekta solutions across over 130 countries. Elekta is headquartered in Stockholm, Sweden, with over 4,000 employees and offices in more than 40 countries. The company is listed on Nasdaq Stockholm. For more information, visit elekta.com.
Description
The Imaging Safety Engineer is responsible for ensuring that Elekta Imaging products are developed, maintained, and released in compliance with applicable safety standards, regulatory requirements, and company Quality Management System (QMS) processes. The role provides safety engineering expertise throughout the product lifecycle, including concept development, design, implementation, verification, validation, release, and maintenance. The Imaging Safety Engineer works closely with System Engineering, Software Development, Verification & Validation, Quality Assurance, Regulatory Affairs, and Product Management teams to identify, assess, and mitigate product risks.Responsibilities
Responsible for ensuring the safety compliance of Imaging products throughout the product lifecycle. The role supports risk management activities in accordance with applicable standards and regulations, conducts safety analyses and assessments, maintains safety documentation, participates in design reviews and change evaluations, and collaborates with cross-functional teams to identify, mitigate, and monitor product safety risks while supporting regulatory and quality compliance activities.Authorities
The Imaging Safety Engineer is authorized to:- Review and approve safety-related analyses and documentation within assigned projects.
- Escalate safety concerns and unresolved product risks to project leadership and management.
- Request additional risk assessments or safety analyses when necessary.
- Recommend implementation of risk control measures and corrective actions.
- Participate in design reviews, change reviews, and release readiness assessments.
- Recommend delaying or preventing product release when unacceptable safety risks remain unresolved.
Relevant Knowledge, skills and competencies
Master's degree in engineering. Good understanding of medical device development processes, software and systems engineering, and safety risk management principles. Familiarity with standards such as ISO 14971, IEC 62304, and IEC 60601 is required. Knowledge of hazard analysis, FMEA, risk assessment methodologies, and regulatory compliance practices is preferred. Strong analytical, communication, and cross-functional collaboration skills are essential.Engineering & Science - Safety Engineer · Elekta, Inc.