Senior Manufacturing Engineer

Job Description

Join to apply for the Senior Manufacturing Engineer role at Vital Bio.

In this Senior Technical role, you will be responsible for establishing scalable manufacturing processes and transferring new products from engineering and assay development into manufacturing. This includes designing and developing assembly processes that ensure consistent, cost-effective production of high-quality, repeatable assemblies through manufacturing scale-up and steady-state production in a cGMP environment. Responsibilities also involve defining Critical to Quality and Critical to Performance criteria, investigating and assessing technologies, developing and implementing equipment and automation, and optimizing assembly sequences based on lean principles. You will evaluate new processes and equipment, make/make recommendations, and facilitate technology transfer to third-party vendors.

What you'll do:

• Lead design and development of robotic instruments and fluidic systems for Vital Bio’s diagnostic platforms.
• Mentor junior engineers and foster a culture of innovation and continuous improvement.
• Drive Design for Excellence (DFX) initiatives to optimize manufacturability, usability, and reliability.
• Oversee cross-functional projects integrating mechanical systems with electrical, software, and consumables engineering.
• Develop and execute test strategies for validation at various system levels.
• Champion prototyping using advanced tools and ensure scalability for production.
• Manage technical documentation in compliance with ISO 9001 and regulatory standards.
• Address complex engineering challenges through root cause analysis.
• Collaborate with clinical partners to translate workflow insights into engineering solutions.
• Design manufacturing processes, conduct process development, and support technology transfer activities.
• Provide guidance on manufacturability, risk assessment, and process impacts across teams.
• Lead projects to establish new manufacturing processes, managing objectives and schedules.
• Support the development of scalable processes with appropriate controls and documentation.
• Lead validation activities, including equipment qualification and process validation.
• Maintain manufacturing equipment and documentation, including SOPs and work instructions.
• Perform root cause analysis of manufacturing failures and lead continuous improvement initiatives.

What you will bring:

• Bachelor’s degree in STEM.
• 10+ years of manufacturing engineering/operations experience in Diagnostics or similar industries.
• Strong analytical, problem-solving, and communication skills.
• Experience with manufacturing of reagents, consumables, and instruments for IVDs, including validation and cGMP processes.
• Excellent organizational skills and ability to manage multiple projects.
• Proven collaboration skills across cross-functional teams.

What would be really exciting:

• Six Sigma or Lean certification and practical experience applying these methodologies.
• Knowledge of global IVD manufacturing regulations.
• Experience with high-volume automated assembly processes.
• Project management experience and team leadership.
• An appreciation of puns!

About Vital:

Vital is revolutionizing point-of-care diagnostics with the VitalOne platform, aiming to make healthcare more accessible and proactive. Our diverse team thrives on innovation and impactful work, committed to transforming healthcare access worldwide.

Vital Biosciences Inc. is an equal opportunity employer and values diversity. We accommodate individual needs in our hiring process. Please contact us in advance if you require accommodations.