Do you want to join us in helping to fight the world’s most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.
At Siemens Healthineers, we offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally.
Our Global Team:
We are a team of more than 72,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.
Our Culture:
We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.
Varian currently has an opportunity for a Medical Device Risk Manager. You will be part of the Varian Interventional Solutions (VIS) Quality Team, aligning with Varian’s global medical device risk management program and ensuring compliance with international medical device standards. You will provide guidance and support to enable cross-functional teams within VIS to develop and maintain risk management files for VIS’ medical devices. This role is key to patient safety.
You are responsible for:
Leading Risk Management efforts, processes and process improvements for the Varian Interventional Solutions Products
Collaborating with VIS product development and post market teams to ensure the comprehensive implementation and maintenance of Varian’s risk management procedure in accordance with ISO 14971
Developing and maintaining Risk Management Files for EU class IIb and III device families that includes risk management plans, hazard analyses and risk assessments
Collaborating with the Global Risk Management team to remain abreast of changes to regulations and standards as they relate to risk management
Participating in regulatory inspection and notified body audits
May require direct interaction with regulatory agencies on defined matters
Driving continuous improvement efforts, through facilitating, leading, and collaborating with cross function teams
Minimum Qualifications:
Bachelor’s degree in Science or Engineering with at least 8 years of related experience
Proven experience in medical device risk management
Medical Device Design and Development experience and pharma experience a plus
Knowledge and understanding international safety standards for medical devices (e.g. IEC 60601 series, IEC 62304, etc.)
Related experience with US Class II or III (EU class IIb or III) medical devices highly desired
A knowledge of ablation (e.g. cryoablation, microwave) or embolic products is highly desired
Proficient in utilizing business tools such as: E-mail, Microsoft Word, Excel, Visio, and PowerPoint.
Willingness to travel occasionally for collaborative global process work and skills development - up to 20%
At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.
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Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers Career Site.
As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.