Bachelor's or Master's degree in life science, biomedical/engineering, or related field; equivalent experience considered.
Experience in planning, executing, and reporting studies in medical device development, including late-stage R&D and V&V.
Ability to integrate work across scientific and engineering disciplines, including assay, software, hardware, consumable, and manufacturing.
Familiarity with CLSI guidelines for method evaluation and studies.
Experience in writing and managing SOPs, work instructions, and study protocols in a regulated environment.
Experience managing operators or research staff, including training and qualification.
Proficiency with requirements management tools (e.g., Jira, eQMS) and Microsoft Office/Google Workspace.
Responsibilities
Strategize and orchestrate cross-functional handoffs across various teams, defining inputs, outputs, and timing.
Act as the liaison between teams, translating requirements and resolving ambiguity in scope.
Identify integration points and dependencies across functions to ensure smooth study execution.
Plan studies throughout the development lifecycle, including preclinical and clinical preparations.
Execute studies per approved protocols, coordinating with responsible teams for resources and needs.
Manage samples for studies, including sourcing, tracking, and allocation.
Author and manage study documentation, ensuring version control and compliance.
Benefits
Onsite work environment fostering collaboration and team engagement.
Full Job Description
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.
The compensation range for this role is $80,000 - $95,000 CAD. Compensation will be determined based on the individual's demonstrated experience, education, training, relevant certifications or licensure, and other applicable business and organizational factors.
This role is a current, onsite vacancy.
About Vital Biosciences Inc
Vital Biosciences is a medical device company that develops non-invasive monitoring solutions for critical care patients. The company's products include a wearable device that measures blood glucose levels and a non-invasive device that measures intracranial pressure. Vital Biosciences' technology is based on optical sensing and machine learning algorithms. The company's products are designed to improve patient outcomes and reduce healthcare costs. Vital Biosciences serves hospitals and healthcare providers.
