Product Risk Manager – Radiation Oncology

We don’t just build technology. We build hope for everyone dealing with cancer.

The Product Risk Manager is responsible for assessing and mitigating potential risks associated with software product development and post-market defects reported against released software. Key responsibilities include identifying risks early in the product lifecycle, collaborating with cross-functional teams to implement risk management strategies, and ensuring compliance with regulatory standards. The role involves proactive monitoring of product performance post-market, conducting risk assessments, and completing corrective actions as necessary. Post-market monitoring is completed for Monaco, MOSAIQ (both Medical Oncology and Radiation Oncology), Smart View, Teleport, Voice/Assist, Elekta Physics Platform, AQUA (E2EQA), and ProKnow.

Senior Product Risk Manager role (in addition to Product Risk Manager):

• Advanced degree in Medical Physics, Dosimetry, Computer Science or other related science.
• Advanced specialist knowledge in a specific engineering discipline or product, with an understanding of system-level requirements.
• Highly conversant with a range of Elekta products and awareness of their clinical applications.
• 5 years or more technical experience relevant to the role and complex products or systems.
• Proven leadership skills within a defined scope and the ability to coach others.

Lead Product Risk Manager role (in addition to “Senior” level):

• Advanced degree in Medical Physics, Dosimetry, Computer Science or other related science.
• Highly conversant and experienced with a range of Elekta products. Knowledgeable in the business line product portfolio.
• 10 or more years of successful and specific technical experience of complex products or systems.
• Proven leadership skills – 3 years or more of technical leadership experience with complex systems.
• A mentor and coach of developing colleagues.

Responsibilities:

• Conduct risk assessments throughout the product lifecycle.
• Develop risk management plans and strategies.
• Collaborate with product development teams to integrate risk management into project planning.
• Monitor product performance and conduct post-market reviews to process complaints on released software.
• Conduct reviews of competitor’s software products to prevent similar issues in Elekta’s software products.
• Ensure compliance with regulatory requirements and industry standards.
• Provide guidance to internal stakeholders on risk management practices.
• Communicate findings and recommendations to senior management.
• Maintain general radiation therapy knowledge.
• Maintain risk management knowledge and application.
• Proactively identify and improve process gaps and product deficiencies.
• Expert in service support and safety processes, applying logic and process in complex situations.
• Mentor and develop team members - technical and service skills.
• Empower and guide others with proactive and insightful mentorship within the organization.
• Drive service innovation and influence the service and technical product roadmap.
• Be a representative during regulatory and quality audits as a Subject Matter Expert.
• Lead root cause cross-functional investigation for safety events impacting the install base.
• Deputize for reporting line Manager.
• Approval of risk assessments relating to field events.
• Establish and deploy immediate corrective actions to clinical systems.

Qualifications:

• Bachelor’s degree in a relevant field.
• Excellent analytical and problem-solving skills.
• Effective communication and interpersonal skills.
• Membership to a relevant professional body is desired.
• Safety process and assessment experience applied to complex systems (5 years minimum) and ideally with medical devices.
• Experience of auditing processes and being audited within highly regulated industries.
• Understanding of industry standards such as ISO 14971, etc.
• Strong, proactive communication skills using all available tools. Concise and coherent written work.
• English language – education taught in English or having passed a Secure English Language Test (SELT) to at least level B1 (CEFR) or similar recognized test.
• Detail-oriented, analytical, with excellent problem solving and troubleshooting abilities.
• Ability to work independently and collaborate with colleagues in other departments, business areas, and regions.
• Ability to operate at multiple levels of an organization and in an international/multi-cultural environment.
• To engage and uphold Elekta’s values and to represent Service in a professional and positive manner.
• Experience with HPALM, JIRA, CLM and Polarion for tracking software defects and customer complaints.
• Aware of the Elekta product portfolio with experience in one or more products. Basic clinical application awareness.

Physical Requirements:

• Must be able to work in and around radiotherapy equipment and high field magnetic fields (in excess of 1.5 Tesla).
• Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

Physical Demands:

• Stand, walk, sit, use steps/ladders, and use hands to handle objects and tools; reach with hands and arms, talk and hear. Must occasionally lift and/or move light to moderate weight. Specific vision abilities required include close vision and the ability to adjust focus.

Work Environment:

• The noise level and temperature in the work environment is usually moderate.

Travel:

• Must be able to travel internationally up to 25% of the time.

What you’ll get:

In this role, you will work for a higher purpose; hope for everyone dealing with cancer, and for everyone regardless of where in the world, to have access to the best cancer care. In addition to this, Elekta offers a range of benefits.

What we offer:

• Opportunity to work with a proactive and supportive team
• Hybrid work option (you are required to work on location at least 3 days/week)
• Excellent Medical, Dental and Vision coverage
• 401k, paid Vacation and Holiday
• A range of additional benefits including wellness reimbursement, tuition reimbursement and flexible spending account
• Opportunity to work on cutting edge in medical advancement.
• Close-knit company culture
• Upward mobility

How to proceed?

We are looking forward to hearing from you! Apply by submitting your application and résumé in English. Please note that we do not accept applications by e-mail.