Caris Life Sciences · 17 hours ago
Senior Staff Design Quality Engineer - Hybrid
Tempe, AZ
Full-time
Hybrid
Senior Level, Lead/Staff
10+ years expCaris Life Sciences is transforming cancer care and improving lives through precision medicine. The Senior Staff Design Quality Engineer will lead quality activities related to design and development, risk management, and ensure compliance with regulations while collaborating with cross-functional teams.
BiotechnologyArtificial Intelligence (AI)HealthcarePharmaceuticalLife ScienceBiopharmaHealth Care
Responsibilities
Lead planning and execution of the new product development and design change projects with focus on Design Controls and Risk Management activities
Work effectively with cross- functional teams for the harmonization and consistency across several projects
Take ownership of the processes (Design Controls and Risk Management). Identify improvement opportunities, lead cross functional teams to implement the process improvements
Provide mentorship, guidance and training to the product development teams new
Support the implementation of eQMS tools for design controls and risk management (eDHF)
Lead Design Reviews with participation from the core teams
Provide review and approvals of DHF deliverables such as verification and validation plan, protocol/report, requirements, and specifications
Lead creation of risk management file with support from the cross-functional product development teams, risk management plan/report, hazard analysis, dFMEA, uFMEA
Maintain risk file in the post market lifecycle phase
Support design transfer activities including BOM and DMR
Assist in regulatory inspection readiness activities and provide support during regulatory site inspections
Participate in process improvement initiatives as necessary, performing gap analysis
Perform root cause analysis, CAPA, closure of audit/inspection observations, and other QMS activities related to design controls and risk management
Qualification
Required
Minimum 10+ years of hands-on experience, or relevant comparable background
Advanced understanding of the ISO 13485, FDA QSR/21 CFR Part 820, ISO 14971
Basic understanding of the IEC 62304, 62366 standards
Technical expertise and understanding of IVD assays and data analysis tools
Experience in successfully leading new product development teams through design controls and risk management processes, including DHF documentation including product risk file
Requires strong oral and written communication skills and interpersonal skills
Preferred
Experience with IVDR, CAP/CLIA and GCP/GCLP preferred
Working knowledge of and proficiency in U.S. and International medical device regulations and implementing Quality Systems
Experience with mentoring junior people on the team
Adaptable to fast-paced, dynamic work environment with shifting demands
Company
Caris Life Sciences
Caris Life Sciences develops molecular profiling and AI-driven technologies to support precision medicine in oncology.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
$1.86BKey Investors
BraidwellOrbiMedSixth Street
2025-06-18IPO
2025-04-07Private Equity· $168M
2023-01-19Debt Financing· $400M
Leadership Team
Luke Power
Chief Financial Officer
Brian Stengle
SVP, Chief Marketing Officer
Recent News
2026-02-04
2026-02-03
2026-02-03
Company data provided by crunchbase