T45 Labs

Operations

• Manage the contract lifecycle, including intake, drafting from approved templates, redlining, negotiation within approved guidelines, approval routing, execution, and renewal tracking
• Negotiate and manage vendor, consulting, nondisclosure, software, supply, and services agreements within established authority
• Coordinate clinical trial agreements, site budgets, and CRO contracts with Clinical Affairs and outside counsel
• Build and maintain contract templates, playbooks, approval workflows, and a signature authority matrix
• Escalate non-standard terms and material risk issues to outside counsel with clear summaries and proposed next steps
• Maintain corporate records, including board and committee minutes, consents, bylaws, and entity records
• Prepare board meeting materials and coordinate the quarterly board meeting cycle
• Administer equity documentation in Carta, including option grant approvals, board consents, and 409A records, in partnership with Finance and HR
• Coordinate data rooms, diligence requests, and closing checklists for financing transactions
• Manage outside counsel engagements, legal spend, and budget-to-actual reporting
• Implement and administer a scalable contract management system
• Track intellectual property matters with patent counsel, including filings, deadlines, and invention disclosures
• Coordinate policy records, employment agreements and state addenda, and regulatory documentation with appropriate internal teams and counsel
• Report on contract volume, cycle times, and legal spend

Legal Operations Manager

Systems Engineer

• Develop, document, and maintain user, system, subsystem, and product requirements
• Translate clinical, user, business, and technical needs into clear, measurable, and testable design inputs
• Maintain bidirectional traceability among user needs, design inputs, risk controls, verification and validation activities, and design outputs
• Identify documentation gaps, conflicts, and dependencies and support DHF and project files during audits and regulatory reviews
• Support product risk-management activities throughout the development lifecycle
• Develop and maintain hazard analyses, design/use/process FMEAs, risk evaluations, risk-control measures, and risk traceability
• Facilitate cross-functional risk discussions and ensure risk controls are incorporated into requirements, design outputs, and verification activities
• Evaluate new information, design changes, and test results for impact on the risk management file
• Develop and maintain design verification and validation strategies, plans, protocols, test methods, acceptance criteria, and reports
• Coordinate and participate in laboratory, bench, and system-level testing
• Review test data and document technical conclusions
• Investigate test failures, anomalies, and unexpected results, including root-cause evaluation and follow-up documentation
• Collaborate with internal teams and external laboratories or vendors to plan and execute testing
• Support design-control activities from development planning through design transfer
• Help maintain an inspection-ready Design History File
• Communicate technical risks, dependencies, decisions, and testing status to project stakeholders
• Contribute to technical problem-solving, design reviews, development planning, and continuous improvement
• Own failure investigations, Health Hazard Evaluations, Nonconformance Reports, and Corrective and Preventive Actions
• Work cross-functionally with R&D, Quality, Clinical, Regulatory, and Manufacturing

Legal Operations Manager

R&D Systems Engineer