Manufacturing Engineer II

About you:

You are a hands-on technical problem solver with deep experience in transferring products from R&D to manufacturing in a cGMP-regulated environment. You thrive at the intersection of engineering, automation, and operations—designing and optimizing assembly processes and applying lean six sigma manufacturing principles that ensure quality, reliability, and efficiency from prototype through scale-up. You approach each challenge with a disciplined, data-driven mindset, excel at cross-functional teamwork, and are energized by continuous improvement and innovation. You're ready to contribute your expertise to help Vital Bio bring diagnostics to life.

What you'll do:

• Lead the transfer of new products and manufacturing processes from engineering and assay development into a cGMP manufacturing environment.

• Design, develop, and implement robust manufacturing processes and scale-up activities for combination consumable assemblies (reagents with molded plastic components) and diagnostic instruments.

• Provide DFx input to new designs and processes, ensuring the manufacturability and scaleability of new designs.

• Define and evaluate different assembly strategies, introduce equipment and process automation where appropriate, and maintain cost-effective, high-quality, repeatable operations from prototypes through production.

• Develop process flow maps, optimize assembly sequences applying lean principles, and recommend new processes/equipment—including Make/Buy decisions and third-party transfers.

• Develop and execute design transfer plans for new products and/or processes, ensuring that manufacturing equipment, controls and processes are capable of meeting the design requirements, identifying any gaps and establishing robust plans to close those gaps as part of the development effort.

• Serve as the manufacturing subject matter expert, identifying risks and mitigation strategies related to process steps, raw materials, and product performance throughout tech transfer.

• Collaborate closely with engineering, assay development, manufacturing and supply chain teams to ensure effective inventory management and prototype material supply for verification and validation needs.

• Establish and maintain manufacturing controls and documentation, including SOPs, work instructions, acceptance plans, and compliance with ISO 13485 and cGMP.

• Plan and execute comprehensive validation protocols for equipment, facilities, and processes (IQ, OQ, PQ).

• Support procurement, installation, qualification, and maintenance of critical manufacturing equipment.

• Perform root cause analysis for manufacturing failures with cross-functional teams and implement process improvements.

• Proactively identify and drive opportunities for continuous improvement in manufacturing operations.

What you need:

• Bachelor's degree in a STEM discipline.

• 5+ years' significant manufacturing engineering or related operational experience in diagnostics or similar fields combining biologicals/reagents with injection-molded plastics.

• Proven ability to apply critical thinking, analytical reasoning, and experimental design to solve complex manufacturing problems.

• Strong familiarity with manufacturing of reagents, consumables, and instruments for IVDs, tech transfer, cGMP processes, and validation/qualification requirements.

• Experience collaborating with cross-functional teams and managing multiple projects simultaneously.

• Excellent communication skills and sharp attention to detail.

• Highly organized with a proactive, solutions-oriented approach.

Bonus points for:

• Six Sigma and/or Lean certification, with practical experience using these tools for process improvement.

• Prior experience with high-volume automated assembly and global IVD manufacturing regulations.

• Project management experience and leadership of project teams.

• An appreciation for puns and a willingness to pitch in wherever needed

Why Join Us?

At Vital Bio, you will:

• Take a critical role in building and scaling manufacturing operations for novel diagnostics, impacting global healthcare systems.

• Work alongside passionate problem-solvers in a culture that values curiosity, teamwork, and innovation.

• Own your contributions on projects with meaningful, real-world outcomes.

• Grow your skills in a supportive, dynamic environment that believes fun and excellence go hand-in-hand.

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