Supervisor - Systems Engineer
Caris Life Sciences
At Caris, we understand that cancer is an ugly word—a word no one wants to hear, but one that connects us all. That’s why we’re not just transforming cancer care—we’re changing lives.
We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day: “What would I do if this patient were my mom?” That question drives everything we do.
But our mission doesn’t stop with cancer. We're pushing the frontiers of medicine and leading a revolution in healthcare—driven by innovation, compassion, and purpose.
Join us in our mission to improve the human condition across multiple diseases. If you're passionate about meaningful work and want to be part of something bigger than yourself, Caris is where your impact begins.
Position Summary
This position is responsible for supervising core duties and personnel within the Systems Engineering team. This role will oversee equipment verifications in the MI Cancer Seek (FDA) and Caris Assure (CAP/CLIA) laboratories and associated operations including IHC, Digital Pathology, Laboratory Operations, and Research and Development. This supervisor also supports software validation, system administration, project management, and the Cross Correlation Program.
Job Responsibilities
- Ensure equipment verification record compliance with all applicable regulatory requirements (CLIA, NYS, CAP, ISO, FDA, IVDR, etc.).
- Quality review CMMS work orders and associated documentation generated from all Phoenix sites.
- Oversee use of software tools including the CMMS and electronic logbook platform to provide training, end user support, and quality review.
- Manage the CAP-required Cross Correlation program and associated records.
- Author, review, revise, and implement standard operating procedures (SOPs).
- Participate in internal and external audits with tasks such as audit preparation, answering questions, and providing documentation to auditors.
- Support various projects and initiatives within the System Engineering teams.
- Manage company records in accordance with regulatory requirements and company policies.
- Engage in cross-functional collaborations between Systems Engineering, Laboratory, IT, Software QA, and Quality teams to support program alignment between organizational and regulatory requirements.
- Supervise applicable personnel and tasks as delegated by Systems Engineering Management.
Required Qualifications
- Bachelor’s degree in engineering, biological science, computer science, or similar field
- Three years of experience working in a regulated environment (CAP, CLIA, NYS, FDA, ISO, etc.).
- A strong knowledge of requirements per CAP/CLIA, ISO 13485, 21 CFR 820, and 21 CFR Part 11.
- Previous experience supervising and/or training other on processes.
- Knowledge of laboratory practices, instrumentation, safety procedures, etc.
- A drive for results (Service, Quality, and Continuous Improvement) in a fast-paced laboratory environment.
- Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook, and general working knowledge of Internet for business use.
Preferred Qualifications
- Three years of experience working in a quality or engineer role within a regulated laboratory environment with a focus on laboratory instrumentation and equipment.
- Experience leading or directly supporting complex projects like process improvement and software implementations.
- Master’s degree in biological science, chemistry, engineering, or related field.
- Lean Six Sigma Certified
Physical Demands
- Employee must be able to use standard office equipment.
- Employee must have ability to sit and stand for extended periods of time.
- Work is split between a desk/cubicle environment and a laboratory environment. Employee may have exposure to high noise levels, fumes, and biohazardous materials in the laboratory environment.
Training
- All job specific, safety, and compliance training are assigned based on the job functions associated with this employee.
Other
- This position requires some evenings, weekends and/or holidays.
Conditions of Employment: Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification.
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.