Software Service Validation Lead

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

Preferred Location: San Jose, CA

Technical Service Validation ensures that defined requirements are met that allow Elekta’s Installation, Upgrade & Support teams to deploy, configure, and maintain software solutions in their intended operational environment whilst also meeting the need of hospital IT departments. The Technical Service Validation team are also responsible for deploying & maintaining the validation environments utilised by Clinical & Physics validation teams.

The Software Service Validation Lead oversees the technical software service validation across the Business Line Oncology Software Solution’s product portfolio, ensuring compliance with industry standards while bridging the gap between clinical validation and technical teams.

The Software Service Validation Lead is responsible for developing and implementing the technical validation & validation environment strategy, managing team validation capabilities, and maintaining quality standards across service validation activities.

Responsibilities -

• Develop and maintain the Technical Service Validation Strategy in accordance with Elekta’s overall Software Validation framework & strategy; this includes test case definition, management, and execution methodologies
• Create where necessary, maintain & drive implementation of SOPs and work instructions to be implemented by Technical Service Validation specialists; enabling Technical Service Validation Specialists to create and execute appropriate test cases and appropriately raise defects found during technical validation in appropriate Elekta Business Systems.
• Act as the primary interface between clinical validation teams and technical service validation specialists
• Maintain a matrix of resources allocated to product validation activities and align with GPSE on resource allocations
• Establish and maintain technical service validation procedures that align with regulatory requirements and industry best practices
• Lead and mentor technical service validation specialists, fostering a culture of quality and compliance
• Ensure all technical software validation activities are executed in compliance with required standards and regulations
• Develop and maintain validation documentation standards
• Review and approve validation plans, protocols, and reports
• Monitor and report on validation metrics and compliance using Elekta business systems (Polarion/Jira)
• Determine correct training & certification path for technical software validation specialists
• Ensure proper documentation of team training and qualifications
• Ensure validation environments accurately reflect production conditions, define and maintain a framework for validation environment deployment & auditing
• Align with other key stakeholders (Test Facilities, Elekta IT & Networking Teams, Product DevOps teams) to maximise deployment reusability, maintain environment stability and availability, Identify opportunities for automation and efficiency improvements
• Publish & maintain visibility of resources allocated to validation activities
• Align with GPSE on resource allocations

Qualifications -

• Educated to degree or diploma in Computer Sciences OR associated fields OR proven and demonstrable knowledge comparable to this requirement
• Solid and demonstrable understanding of technical aspects around the use, deployment and maintenance of Elekta’s Oncology Informatics software products with a minimum of 5+ years’ experience
• Proven ability to break down, document and talk about complex technical issues & requirements
• 5+ years’ experience in medical device or healthcare software validation, experience with validation tools and methodologies; relevant formal certifications desired
• Knowledge of ISO 13485, IEC 62304, or similar standards desired
• Certification in quality management systems or software validation desired
• Experience in DevOps practices and methodologies desired
• Experience with infrastructure-as-code and configuration management tools, understanding of CI/CD principles and practises desired
• Experience with scripting languages desired
• Excellent communication and interpersonal skills with proven strong analytical and problem-solving abilities
• Proven ability to work in a team and across time zones and cultures
• Excellent written & spoken professional business English skills required

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 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

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.

We are an equal opportunity employer.

The US base salary range for this position is $170,000-190,000.

About Elekta

As a leader in precision radiation therapy, Elekta is committed to ensuring every patient has access to the best cancer care possible. Elekta is a proud innovator and supplier of equipment and software used to improve, prolong, and save the lives of people with cancer and brain disorders.