Senior Manufacturing Engineer

About you:

In this Senior Technical role, you will be responsible for the successful establishment of scalable manufacturing processes and transfer of new products from engineering and assay development into manufacturing, including designing, and developing assembly processes that assure the consistent and cost-effective production of high-quality, repeatable assemblies through manufacturing scale-up and steady-state production in a cGMP environment. This will include defining Critical to Quality and Critical to Performance criteria for new designs, investigating and assessing different technologies and determining their suitability for use for a given design, then developing, procuring and implementing, equipment and automation for the prototyping, scale-up, and production of sub-assemblies, and final assemblies. Developing process flow maps and optimal assembly sequences, based on the application of lean principles, as well as investigating, evaluating, and recommending new processes and equipment, Make/Buy recommendations, and transferring to third-party vendors as appropriate.

What you'll Do:

• Lead the design and development of robotic instruments and fluidic systems for Vital Bio’s diagnostic platforms, ensuring alignment with clinical and operational requirements.
• Mentor and guide junior engineers, providing technical oversight and fostering a culture of innovation, accountability, and continuous improvement.
• Drive DFX (Design for Excellence) initiatives, optimizing for manufacturability, usability, and reliability in next-generation medical devices.
• Oversee cross-functional projects, collaborating with electrical, software, and consumables engineers to integrate mechanical systems with broader platform architectures.
• Develop and execute advanced test strategies to validate component, subsystem, and full-system performance under real-world conditions.
• Champion prototyping and fabrication using cutting-edge tools (3D printing, CNC machining) while maintaining scalability for production.
• Own technical documentation, including design specifications, test protocols, and manufacturing workflows compliant with ISO 9001 and other regulatory standards.
• Troubleshoot complex engineering challenges, leading root-cause analyses for design, manufacturing, and material issues.
• Engage with clinical partners to observe workflows and translate insights into user-centric engineering solutions. Execute the transfer of manufacturing processes and technologies from Research and Process Development groups into a cGMP environment;
• Design the appropriate manufacturing processes, define and conduct process development activities, and provide design transfer inputs required as part of Tech Transfer;
• As a senior manufacturing Subject Matter Expert, you will understand how all aspects of manufacturing, supply chain, quality and facilities come together to ensure a scalable production process and will provide guidance to other teams about manufacturability, identify potential risks, evaluate impacts of manufacturing process steps and raw materials on product performance, and develop risk mitigations;
• Lead projects and teams in the development of robust, structured plans for the establishment of new manufacturing processes, defining key objectives and schedule and then managing the successful project execution;
• Provide Manufacturing Engineering guidance and support to the Assay Development and Engineering teams to ensure the development of scalable processes and methodologies with process capability that matches the design requirements;
• Establish appropriate manufacturing processes and controls to create and maintain consistency and quality of manufacturing from prototype through production scale-up;
• Utilize your knowledge and experience to define, develop, assess, implement, and continually enhance cGMP manufacturing processes and operations;
• Lead comprehensive validation activities including planning, writing and execution of validation protocols for equipment, facilities, and processes;
• Identification, procurement, installation, qualification (IQ, OQ, PQ), and maintenance of critical manufacturing equipment;
• Create and maintain cGMP manufacturing documentation (e.g., Work Instructions, in-process, and final acceptance plans and records);
• Support the creation and maintenance of Standard Operating Procedures (SOPs) for ISO13485 and cGMP processes;
• Perform Root Cause Analysis of manufacturing failures, in collaboration with cross-functional team members, to determine failure causes, and define and implement improvements to address the causes of failures;
• Lead and mentor co-ops and junior level engineers, providing direction and feedback on the development and execution of experiments, investigations and process development activities;
• Drive Continuous Improvement in manufacturing by defining improvement opportunities and developing and implementing process improvements in collaboration with the manufacturing team.
  
  

What you will Bring:

• Bachelor’s degree in STEM;
• 10+ years of significant manufacturing engineering and/or operational experience in Diagnostics or similar industries combining biologicals and reagents with injection molded components and instruments;
• Demonstrated critical thinking and analytical reasoning skills;
• Ability to apply a disciplined engineering approach to define and execute designed experiments, analyze data as well as define problems, collect data, establish facts, and draw valid conclusions;
• Familiarity with the manufacturing of reagents, consumables, instruments for IVDs, validation/qualification requirements, and cGMP processes;
• Excellent communication skills and attention to detail;
• Strong organizational skills and ability to multitask across projects and activities;
• Proven ability to collaborate and work effectively with cross-functional teams.
  
  

What would be really Exciting:

• Six Sigma and/or Lean certification with demonstrated experience in applying the tools and methodologies to real-life practical situations;
• Familiarity with global IVD regulations related to manufacturing;
• Prior experience with high-volume automated assembly processes;
• Experience with Project Management and leading project teams;
• An appreciation of puns!
  
  

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.