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. 
