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.