Product Risk Manager - Radiation Oncology

$120,000 - $145,000/Yr

Elekta - Atlanta, GA

Full-time - Mid Level

Hybrid - Atlanta, GA

Professional, Scientific, and Technical Services

About the position

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.

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.
• 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.
• Represent 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 assessment relating to the field events.
• Establish and deploy immediate corrective actions to clinical systems.

Requirements

• Bachelor's degree in 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 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 and has 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.
• Awareness of the Elekta product portfolio with experience in one or more products. Basic clinical application awareness.

Nice-to-haves

• 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.
• 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.

Benefits

• 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 health 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.