About you:

You are a detail-oriented systems thinker who bridges scientific and engineering disciplines across assay, software, hardware, consumable, and manufacturing perspectives. You focus on the how of inter-team study delivery rather than portfolio-level program management, and you're comfortable acting as the scientific and operational liaison between teams, translating requirements and resolving ambiguity in scope. You bring strong technical writing, communication, and conflict-resolution skills to a hands-on integration and study-execution role.

What you'll do:

• Strategize and orchestrate cross-functional handoffs across assay, software, hardware, consumable, and manufacturing teams, defining inputs, outputs, acceptance, and timing for each transfer from Phase II exit through V&V, preclinical, and beyond.

• Act as the scientific and operational liaison between teams, translating requirements, resolving ambiguity in scope, and ensuring each function understands what it is receiving and what it owes downstream.

• Identify integration points and dependencies that span functional boundaries, designing how data, samples, builds, releases, and documentation flow between teams to keep studies unblocked.

• Plan studies across the development lifecycle, including design characterization, V&V-readiness, preclinical analytical and in vivo/model studies, and clinical-pilot preparation.

• Execute studies per approved protocols, coordinating engineering builds, reagents/consumables, software/firmware releases, instrument units, and biological/sample needs with responsible teams.

• Manage samples used for studies, including sourcing, chain-of-custody, storage, tracking, allocation across study arms, and disposition.

• Author and manage study documentation, including study protocols, work instructions, and SOPs, maintaining version control and ensuring teams work to current revisions.

• Author study reports summarizing methods, data, results, deviations, and conclusions against pre-defined acceptance criteria and CLSI method-evaluation protocols.

• Maintain the study documentation set: protocols, deviation logs, test records, operator log, traceability matrices, and design history file (DHF) inputs supporting the transition into V&V and preclinical evidence.

• Manage operators and the broader study team, coordinating task assignment, training and qualification, scheduling, and performance oversight for study execution activities.

• Surface and resolve cross-functional technical and procedural blockers, supporting technical troubleshooting, root cause investigations, and system-wide improvements.

• Support design reviews, gating decisions, and risk management activities across the R&D-to-V&V transition and preclinical phase.

What you'll need:

• Bachelor's or Master's degree in a life science, biomedical/engineering, or related field; equivalent experience considered.

• Prior experience planning, executing, and reporting studies across the medical device development lifecycle, including late-stage R&D, V&V, and/or preclinical activities.

• Demonstrated ability to integrate work across scientific and engineering disciplines, bridging assay, software, hardware, consumable, and manufacturing perspective.

• Working knowledge of CLSI guidelines and their application to method evaluation, precision, linearity, and method comparison studies.

• Experience writing and managing SOPs, work instructions, and study protocols in a regulated environment.

• Experience managing operators, technicians, or research staff, including training and qualification.

• Proficiency with requirements management tools (e.g., Jira, eQMS) and Microsoft Office/Google Workspace.

• Strong technical writing, communication, and conflict-resolution skills; detail-oriented with systems thinking.

Compensation will be determined based on the individual’s demonstrated experience, education, training, relevant certifications or licensure, and other applicable business and organizational factors.

About Vital Bio