Together, we can beat cancer.

At Varian, a Siemens Healthineers Company, we bring together the world's best talent to realize our vision of a world without fear of cancer. Together, we work passionately to develop and deliver easy-to-use, efficient oncology solutions.

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.

If you want to be part of this important mission, we want to hear from you. 

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%                                                                                                                        

Fighting cancer calls for big ideas.

We envision a world without fear of cancer. Achieving this vision takes dedication and commitment from all of us, every single day. That's why we celebrate and value the distinctly beautiful and intersectional identities of each of our employees. We are a mirror of our patient-base, which allows us to innovate. Big ideas come from everywhere, and the best ideas are fostered by our unique individual experiences. At Varian, we encourage you to bring your whole self to work and believe your bold and authentic perspective will help to power more victories over cancer.

#TogetherWeFight

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Varian is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

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