Position Summary

Sr. Software Design Controls Engineer thinks “outside the box” in the implementation of the Software Design Control and SDLC (software development lifecycle) programs at Caris Life Sciences, providing quality oversight, and ensuring compliance with all applicable regulations and incorporations of software industry best practices. The position will work in collaboration with the Software Development, Bioinformatics, IT, Information Security (InfoSec), Regulatory Affairs, project/program management, and other cross-functional teams throughout the SDLC.

Job Responsibilities

• Supports the implementation of the SDLC and software design controls as per the requirements of ISO 13485/FDA QSR design controls and IEC 62304.

• Participates in process improvement of software design controls and other impacted SDLC processes, work instructions and templates. This includes the ability to perform gap analysis, impact analysis, and risk communication.

• Provide mentorship, guidance, and training to the software development engineering team members new to medical device regulated software development requirements.

• Leads cross-functional team members performing risk management (including cybersecurity risk analysis) and configuration management activities.

• Authors (as needed) and ensures quality records produced during software development, validation, maintenance activities are in accordance with Quality System Requirements which include IEC 62304, ISO 13485, FDA QSR, 21 CFR Part 11, and GAMP5 requirements.

• Leads by example – the ability to author (as needed) and ensure quality records produced during software validation process are accurate, clear, concise, and sufficient for multiple projects at a time. This includes quality oversight on the following documents that support the SDLC processes (as applicable): planning, risk assessment, requirements and specifications, summary reports, trace matrixes, V&V, and cybersecurity related quality records.

• Supports initiative to ensure IT and InfoSec teams maintain compliance to NIST 800-100, ISO 27001, and SOC 2. This includes participating and collaborating with compliance team members to audit current IT and InfoSec practices and ensuring compliance to processes.

• Maintains collaboration and solid communication channels with internal audits and compliance teams for knowledge sharing purposes and to drive operational efficiencies.

• Participates in Supplier Qualification Audits of software suppliers that will be used to support the development of an Off-the-shelf (OTS) computerized system. Partner with a lead auditor to ensure the supplier’s software development and validation practices comply with Caris’s SDLC process.

• Able to work independently with minimal supervision with objectives given by Software Quality Leadership.

• Plan and coordinate own work according to higher-level project schedule demands.

• Assist in internal, external, and regulatory inspection readiness activities and provide support during audits.

• Performs complaint investigations, root cause analysis, CAPA, closure of audit/inspection observations, and other QMS activities related to software design controls and risk management.

Required Qualifications

• Bachelor’s degree in an engineering, scientific or related field with minimum 4+ years of relevant hands-on experience, or relevant comparable background.

• Strong knowledge of SDLC process and the application of IEC 62304, ISO 13485, FDA QSR, 21 CFR Part 11, GAMP5, and FDA Cybersecurity guideline requirements.

• Knowledge of agile/scrum SDLC methodology and its implementation of SDLC practices in a medical device regulated environment.

• Adaptable to fast-paced, dynamic work environment with shifting demands.

• Conditions of Employment: Individuals must successfully complete pre-employment process, which includes criminal background check, drug screening, and reference verification.

Preferred Qualifications

• Knowledge of NIST 800-100, ISO 27001, and SOC 2

• Experience with agile SDLC tools such as Atlassian (JIRA, Confluence and various plug-ins) or GitLab.

• Project experience (preferably 2-4 years of experience) in software validation practices, methodologies, and techniques, preferably in validating medical devices.

• Software development experience.

• Experience in successfully leading new software development teams through the software validation and risk management processes, including producing validation quality records.

• Experience in supporting internal, external, regulatory inspections.

• Knowledge of regulations pertaining to CLIA/CAP/LDT labs, Companion Diagnostic (CDx) or NGS (Next Gen Sequencing) is a plus.

Physical Demands

• Employee may be required to lift routine office supplies and use standard office equipment.

• Ability to sit for extended periods of time.

• Majority of work is performed in a desk/cubicle environment, but at times, may have exposure to high noise levels in the data center, fumes and bio-hazardous material in the lab environment.

• Travel may be required up to 10% of the time.

Training

• All job specific, safety, and compliance training are assigned based on the job functions associated with this employee.

This job description reflects management’s assignment of essential functions. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

Caris Life Sciences is a leading innovator in molecular science and artificial intelligence focused on fulfilling the promise of precision medicine through quality and innovation.

Our laboratory is the heart of what we do. Learn more about our laboratory and the team of histologists who help fulfill our purpose everyday.