Manufacturing Engineer

Vital Bio; Oakville; On-site; CAD 70,000 - 90,000; Full time

Job summary

Vital Bio is seeking a Manufacturing Engineer to join their innovative team. In this technical role, you will facilitate the transfer of new products into manufacturing, ensuring cGMP compliance and optimizing assembly processes. This opportunity requires a Bachelor’s degree in STEM and experience in manufacturing engineering.

Qualifications

• 5+ years of manufacturing engineering experience in diagnostics or related fields.
• Familiarity with cGMP processes and manufacturing of reagents.
• Strong experience with validation and process development.

Responsibilities

• Transfer manufacturing processes and technologies into a cGMP environment.
• Identify risks and develop mitigation strategies.
• Lead validation activities and maintain manufacturing documentation.

Skills

Critical thinking

Analytical skills

Communication

Organizational skills

Collaboration

Education

Bachelor’s degree in STEM

Job description

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About the role

In this technical position, you will be responsible for transferring new products from engineering and assay development into manufacturing, designing and developing assembly processes to ensure consistent, cost-effective production of high-quality, repeatable assemblies. This includes investigating and assessing assembly processes, developing, implementing, and maintaining processes and automated equipment for prototyping, scale-up, and production of sub-assemblies and final assemblies, including reagents with molded plastic components. You will develop process flow maps and optimal assembly sequences based on lean principles, and evaluate new processes and equipment, Make/Buy recommendations, and facilitate transfer to third-party vendors as needed.

Responsibilities

• Execute the transfer of manufacturing processes and technologies into a cGMP environment.
• Design manufacturing processes, define and conduct process development activities, and provide design transfer inputs.
• Identify potential risks, evaluate impacts, and develop risk mitigations during tech transfer and scale-up.
• Interface with engineering teams to define manufacturing and inventory control processes.
• Support assay development and engineering teams to ensure supply of prototype assemblies.
• Establish manufacturing processes and controls to maintain quality from prototype to production.
• Develop and enhance cGMP manufacturing processes and operations.
• Lead validation activities, including planning and execution of validation protocols.
• Procure, install, qualify, and maintain manufacturing equipment.
• Create and maintain manufacturing documentation and SOPs.
• Perform root cause analysis of manufacturing failures and implement improvements.
• Drive continuous improvement initiatives.

Requirements

• Bachelor’s degree in STEM.
• 5+ years of manufacturing engineering or operational experience in diagnostics or similar industries.
• Strong critical thinking, analytical skills, and disciplined engineering approach.
• Familiarity with manufacturing of reagents, consumables, instruments, validation, and cGMP processes.
• Excellent communication, organizational skills, and ability to multitask.
• Proven collaboration skills with cross-functional teams.

Preferred skills

• Six Sigma/Lean certification and application experience.
• Knowledge of global IVD regulations.
• Experience with high-volume automated assembly processes.
• Project management experience.
• Appreciation for puns is a plus!

About Vital

Vital is revolutionizing point-of-care diagnostics with our platform, VitalOne. Our mission is to democratize healthcare technology, making it accessible and proactive. We are a diverse, global team committed to innovation and impact in healthcare.

We are an equal opportunity employer that values diversity. Accommodations are available upon request.

Job details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Engineering and IT