Project Manager - Manufacturing Operations

About you:

You are an experienced project manager with a strong track record of delivering complex, cross-functional initiatives—especially those tied to establishing manufacturing operations and bringing new facilities online. You understand how to navigate the regulated medical device environment while managing aggressive timelines, budgets, and resources in a fast-paced startup setting. You thrive at the intersection of development, operations, and manufacturing, ensuring teams from design through production are aligned, agile, and set up for success.

This is an on-site role in a highly collaborative, hands-on environment.

What you'll do:

• Facilitate and drive the execution of manufacturing-focused development, design transfer, and facility expansion projects from initiation through commercialization.

• Manage weekly task execution, project controls, and KPI tracking to ensure projects meet scope, schedule, and budget.

• Spearhead cross-functional teams spanning manufacturing engineering, assay development, consumable and hardware design engineering, manufacturing, facilities, quality, supply chain, and service.

• Oversee project readiness for design transfer to manufacturing, managing the DMR, ensuring BOM accuracy, procedure readiness, and production documentation is complete.

• Collaborate with manufacturing engineering and operations to develop manufacturing processes, establish production activities and material flow, implement equipment and tooling, and validate manufacturing processes in line with cGMP and ISO 13485 requirements.

• Scope work, identify dependencies, and escalate budget or resource constraints promptly.

• Establish dashboards and standard work processes for project management, monitoring and reporting.

• Maintain close control of project deliverables through regular project meetings, dashboards and ad hoc standup meetings.

• Work with project teams to apply Lean and Six Sigma principles into the development activities.

• Ensure project visibility with clear reporting to leadership and stakeholders.

• Develop and maintain detailed project schedules, dashboards, issue logs, and decision registers.

• Create and execute risk management plans, monitoring risks throughout and implementing contingency actions when necessary.

• Drive process improvement initiatives within the project execution framework to enhance efficiency and repeatability for future facility stand-ups.

• Coordinate with suppliers, contractors, and external partners to ensure equipment commissioning, validation, and readiness for product build.

What You Need:

• Bachelor’s or higher degree in Engineering, Manufacturing, Business Administration, Life Sciences, or a related field.

• 5+ years of project management experience in medical devices or other regulated manufacturing industries, with direct involvement in facility start-up or expansion projects.

• Strong understanding of design transfer, manufacturing operations, and production ramp-up in a cGMP environment.

• Experience with ISO 13485, FDA QSR, and other relevant regulatory requirements.

• Hands-on experience in supply chain coordination, equipment installation, process validation, and manufacturing readiness.

• Excellent organizational skills, attention to detail, and ability to manage multiple workstreams concurrently.

• Strong communication skills with proven ability to collaborate with technical and non-technical stakeholders.

• Proficiency in project management tools such as Smartsheet, MS Project, JIRA, MIRO, or FigJam.

What Excites Us:

• Prior experience launching greenfield or brownfield manufacturing facilities.

• Background in hardware, software, and reagent integration in a regulated environment.

• PMP certification or willingness to pursue.

• Knowledge of Lean, Six Sigma, and process optimization methodologies.

• Experience managing capital equipment projects and validation activities.

• Flexible, hands-on mindset with a passion for problem solving in dynamic settings.

• An appreciation for puns (we take our mission seriously—but not ourselves!).

Why Join Us?

At Vital Bio, you’ll have the unique opportunity to:

• Build and scale manufacturing operations that bring groundbreaking diagnostics from idea to reality, impacting healthcare worldwide.

• Work shoulder-to-shoulder with passionate engineers, scientists, and innovators in a high-energy, supportive environment where your expertise is valued and your contributions make an immediate difference.

• Take ownership of ambitious projects, grow your leadership skills, and help shape the future of our manufacturing capabilities—creating real, lasting value for patients and providers.

• Thrive in a dynamic culture that prizes trust, learning, and not taking ourselves too seriously—puns always welcome!

About Vital

Vital is revolutionizing point-of-care diagnostics with our VitalOne platform, delivering real-time care wherever patients are. Our mission is to democratize health technology, making healthcare more accessible and proactive.

Our global team of experts spans chemistry, software, engineering, and microfluidics. We thrive on change, operate on trust, and value diverse perspectives. Our growth-minded culture empowers front-line decision-making and fosters impactful work.

We seek tenacious, bold individuals ready to transform healthcare. At Vital, your talent will make a difference as we work to ensure everyone has access to care when and where they need it.

Vital Biosciences Inc. is an equal opportunity employer and values diversity in the workplace. We are therefore happy to accommodate any individual needs in keeping with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act. If you require accommodation in order to participate in our hiring process, please contact us to make your needs known in advance