6 дней назад
Safety Engineer (Medical Devices)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Safety Engineer (Medical Devices): Managing product safety and risk throughout the medical device development lifecycle with an accent on regulatory compliance, risk assessment, and post-market monitoring. Focus on interpreting international standards, maintaining risk management files, and collaborating with cross-functional teams to support safe product releases.
Location: Crawley, United Kingdom; hybrid work with four days per week at the Crawley headquarters and one day working from home
Company
develops precision radiation medicine and medical devices for cancer treatment, serving healthcare providers in more than 130 countries.
What you will do
- Lead and support product risk management throughout the medical device development lifecycle.
- Identify potential risks, assess their impact, and define measures to reduce risks to acceptable levels.
- Review and document risk management activities and provide recommendations for product release decisions.
- Ensure products and processes meet applicable regulatory and risk management requirements.
- Collaborate with System Engineers and cross-functional teams to embed safety and risk awareness into product design.
- Prepare risk management reports and support post-market reviews and ongoing product assessments.
Requirements
- Degree in Engineering, Life Sciences, or a related discipline, or equivalent practical experience.
- Experience in product safety, risk management, or a related discipline within medical devices or another regulated industry.
- Understanding of risk management principles across the product lifecycle.
- Knowledge of medical device regulations and experience working in highly regulated environments.
- Experience applying ISO 13485, ISO 14971, IEC 60601, IEC 61508, IEC 62304, FDA, NMPA, and MDR requirements.
- Strong communication and collaboration skills across teams and stakeholders.
Culture & Benefits
- Work focused on improving access to precision radiation therapy and cancer care.
- Up to 25 paid vacation days plus bank holidays.
- Holiday Purchase Scheme and private medical insurance.
- Employer pension contribution package and life assurance.
- Cycle-to-work scheme and electric vehicle salary sacrifice scheme.
- Onsite subsidized restaurant.
Hiring process
- Submit an application and résumé in English through the application portal.
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