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 where engineering, automation, and operations meet: designing, scaling, and optimizing manufacturing assembly processes that ensure quality, reliability, and efficiency. 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 R&D engineering and assay development into a cGMP manufacturing environment.
Design, develop, document and implement robust manufacturing processes and scale-up activities for consumable assemblies (reagents with molded plastic components) and diagnostic instruments.
Provide DFx feedback to ensure manufacturability, scalability, and cost effectiveness of new designs.
Define and evaluate different assembly strategies, identify automation opportunities, and maintain cost-effective, high-quality, repeatable operations;
including Make/Buy decisions and third-party transfers.
Develop process flow maps, optimize assembly sequences applying lean principles, and recommend new processes/equipment.
Serve as the manufacturing subject matter expert, identifying risks and mitigation strategies related to process steps, raw materials, and product performance (and their interactions) throughout tech transfer.
Collaborate cross functionally with R&D engineering, assay development, manufacturing and supply chain teams to ensure effective inventory management and material supply for verification and validation needs.
Establish and maintain manufacturing controls and documentation, including SOPs, work instructions, and acceptance plans, in compliance with ISO 13485, FDA 21 CFR 820, and cGMP.
Plan and execute comprehensive validation protocols for equipment, facilities, and processes (IQ, OQ, PQ and TMV).
Perform root cause analysis for manufacturing failures with cross-functional teams and implement process improvements.
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.
Working knowledge of tech transfer, cGMP processes, process validation / /qualification (IQ/OQ/PQ/TMV), and regulated manufacturing environments.
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.
Experience with statistical process controls (SPC), design of experiments (DOE), and data analysis (Minitab, JMP, Excel).
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.
Experience in scaling up manufacturing operations from pilot scale to full production mode.
Project management experience and leadership of project teams.
An appreciation for puns and a willingness to pitch in wherever needed!
The salary range for this position is $100,000 - 110,000 annually. Compensation will be determined based on the individual's demonstrated experience.
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 VitalVital 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
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