Together, we can beat cancer.
At Varian, we bring together the worlds’ 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. If you want to be part of this important mission, we want to hear from you.
Develop and maintain risk management and cybersecurity documentation for Varian OIS products. REMOTE ROLE USA OR CANADAAbout Varian
Varian Medical Systems’ vision is a world without fear of cancer. To meet this challenge, we equip the world withnew tools to fight cancer. With FY2019 revenues of over $3.0B, Varian Medical Systems develops, manufactures, and services hardware and software products for the treatment of cancer with radiation therapy, proton therapy, brachytherapy, microwave and cryo-ablation and embolic beads. Established in 1948, and headquartered in Palo Alto, Varian continues to grow, with a staff of 8000+ employees globally.
When you join Varian, you’ll be backed by a culture that is centered on fostering your creative potential and experience the full support of an organization and leadership committed to inspiring you to do your best work. Bring your talent to a place where your work will help fight cancer.
Join Varian’s Software Solutions team, and the work you do can make a difference by helping to create a world without fear of cancer. We develop and manufacture products and solutions that innovate, support and streamline cancer-fighting solutions worldwide. Our teams have a common drive to help others, and a passion for excellence.
At Varian, our culture is centered on fostering the creative potential of every employee through teamwork and collaboration. Our technologies touch millions of lives every day, and this inspires us to do our best work – every day. By using your talent, ambition and creativity, you can build a career that allows you to make a real difference in people’s lives. You’re just one click away from the most impactful work you’ll ever do. Apply now and join our mission to help save lives. Someone, somewhere, will be glad you did.
About This Role
This role is critical in the software development life cycle. As a Medical Device Risk Manager, you will work in cross functional teams to make sure our products keep the patients out of harm’s way. This role will challenge you and allow you to work with teams across the globe to support patients in every corner of the earth.
- Lead patient risk management activities and processes within Varian’s design and development life cycle.
- Develop and maintain Risk Management Files for our products including risk management plans, hazard analyses, software analysis, risk assessments, safety/control measures, risk management reports and supplier assessments as defined by our internal processes and external standards.
- Perform reviews of design documentation and deliverable items as the risk management role representative.
- Provide risk management support for post market teams reviewing Varian complaint data and update the risk management file as required.
- Review of post-market surveillance data for Varian and competitive products, including Varian complaint data and publicly available adverse event databases to anticipate and address potential issues.
- Provide leadership and expertise to product development teams to ensure that risk management is implemented consistently through the design process and development activities resulting in improved product safety and quality.
- Ensure risk management procedures, processes and files are updated where required.
- Analysis and assessment of international regulatory requirements for medical device risk management (EU MDR, FDA etc.)
- Continuously maintain expertise and stay up to date on new regulations, standards and technologies that affect Risk Management for medical devices.
- Participate in regulatory audits.
- Willingness to travel occasionally for collaborative global process work and skills development
Required Skills and Knowledge
- Bachelor’s degree
- 3+ years of experience in SQE, Software Development
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.