Medical Device Risk Management Specialist
7 days ago
We are seeking a highly skilled Medical Device Risk Management Specialist to join our team at Starjobs Magyarország. The successful candidate will be responsible for conducting risk management activities, evaluating system and subsystem design tradeoffs, and developing technical specifications for medical devices.
About the Role- Conduct risk analysis, define mitigating measures, and evaluate risks to create a comprehensive risk management file according to ISO 14971.
- Assist project teams in evaluating system and subsystem design tradeoffs to build reliable safety and secure critical architecture.
- Develop technical specifications for medical devices, including functional and non-functional attributes at the system and subsystem levels, and maintain related Design History File (DHF) records.
- Collaborate with international project teams to meet innovation and development milestones and participate in design reviews.
- Maintain and update requirement and verification traceability using risk, requirement, and test management tools.
- Relevant university degree (BSc, MSc or PhD level degree in STEM or Medical field).
- Minimum 3 years of experience in safety risk management in medical device or similar safety-critical industry.
- Excellent command of English language.
- Self-motivated, fast learner who enjoys working with complex systems.
- Innovative spirit, team player, and strong problem solver.
- Result-oriented and open-minded with a can-do attitude.
- Strong verbal and written communication skills.
- Attractive salary: €60,000 - €80,000 per annum, depending on experience.
- Extensive benefits package, including health insurance, retirement plan, and paid time off.
- Dynamic family-owned company culture that promotes constructive exchanges between colleagues, customers, and partners.
- Opportunities for professional growth and development in a rapidly evolving industry.
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