About you:

You are a hands-on, technically driven manufacturing engineer who thrives where product development, automation, and operations meet. You have a proven track record of leading complex product transfers and scaling robust, high quality manufacturing processes in a cGMP regulated environment. You balance strategic thinking with a willingness to get into the details, use data to solve difficult problems, and guide others toward practical, sustainable solutions. You are ready to take technical ownership of critical manufacturing programs and help Vital Bio bring diagnostics to life.

What you'll do:

• Serve as the technical lead for complex manufacturing engineering programs, owning process strategy and execution from development through production scale-up and sustaining operations.

• Lead cross-functional technology transfers from R&D engineering and assay development into cGMP manufacturing, defining key deliverables, technical risks, and manufacturing readiness criteria.

• Design, develop, document, and optimize scalable manufacturing processes for consumable assemblies combining reagents with molded plastic components, as well as diagnostic instruments.

• Provide design for manufacturability / assembly feedback to influence product designs for automation readiness, quality, yield, and cost effectiveness.

• Develop manufacturing and automation strategies, including process flow maps, assembly sequencing, Make/Buy evaluations, equipment selection, and third party transfers.

• Lead critical equipment projects from user requirements and supplier selection through installation, qualification (IQ, OQ, PQ), and production handover.

• Own process characterization, risk assessments (including pFMEA), and manufacturing control strategies; apply DOE, SPC, and data analysis to establish robust and repeatable processes.

• Plan and lead validation activities for equipment, processes, and test methods (IQ, OQ, PQ, and TMV), partnering with Quality to meet ISO 13485, FDA 21 CFR 820, and cGMP requirements.

• Provide technical leadership during complex manufacturing investigations, driving root cause analysis, corrective actions, and sustainable resolution of process or equipment issues.

• Identify and drive continuous improvement opportunities to increase throughput, improve yield and equipment reliability, and reduce manufacturing cost.

• Collaborate with R&D engineering, assay development, manufacturing, Quality, and Supply Chain to resolve technical challenges and support verification, validation, and production needs.

• Mentor manufacturing engineers and technicians, provide technical reviews and guidance, and promote sound engineering practices across the team.

What you need:

• Bachelor’s degree in a STEM discipline.

• 8+ years of progressive manufacturing engineering experience in diagnostics, medical devices, or a similar regulated industry; experience with reagents and injection-molded components is strongly preferred.

• Demonstrated success leading complex manufacturing process development, tech transfer, automation, or production scale-up projects from concept through sustained operation.

• Strong knowledge of cGMP manufacturing, ISO 13485, and equipment/process validation and qualification requirements (IQ/OQ/PQ/TMV).

• Proficiency in structured problem solving, process risk management (pFMEA), statistical process control (SPC), design of experiments (DOE), and data analysis (Minitab, JMP, or Excel).

• Experience developing and reviewing user requirements, process documentation, validation protocols, SOPs, work instructions, and manufacturing control plans.

• Proven ability to provide technical leadership, collaborate across functions, and mentor less-experienced engineers without relying on formal authority.

• Excellent communication skills, sound technical judgment, and the ability to translate complex engineering issues into clear, actionable recommendations.

• Strong organizational skills and the ability to prioritize and drive multiple high-impact projects in a fast-paced environment.

Bonus points for:

• Six Sigma and/or Lean certification, with demonstrated experience leading practical process improvement initiatives.

• Experience specifying, integrating, and qualifying high-volume automated assembly, dispensing, or inspection equipment.

• Familiarity with microfluidics, reagent-based consumables, and global IVD manufacturing regulations.

• Experience managing capital equipment suppliers, technical project budgets, and external manufacturing partners.

• An appreciation for puns and a willingness to pitch in wherever needed!

Why Join Us?

At Vital Bio, you will:

• Take a critical role in building and scaling manufacturing operations for novel diagnostics, impacting global healthcare systems.

• Work alongside passionate problem-solvers in a culture that values curiosity, teamwork, and innovation.

• Own your contributions on projects with meaningful, real-world outcomes.

• Grow your skills in a supportive, dynamic environment that believes fun and excellence go hand-in-hand.

Compensation will be determined based on the individual’s demonstrated experience, education, training, relevant certifications or licensure, and other applicable business and organizational factors.

About Vital Bio