Senior Tooling Engineer
Zoetis
Job Level
Mid-LevelSenior
Tech Stack
Assembly
About the role
- Lead the transfer of new products and manufacturing processes from engineering and assay development into a cGMP manufacturing environment.
- Design, develop, and implement robust manufacturing processes and scale-up activities for combination consumable assemblies and diagnostic instruments.
- Provide DFx input to new designs and processes, ensuring manufacturability and scaleability.
- Define and evaluate different assembly strategies, introduce equipment and process automation, and maintain cost-effective, repeatable operations.
- Develop process flow maps, optimize assembly sequences applying lean principles, and recommend new processes/equipment.
- Develop and execute design transfer plans, identify gaps, and establish plans to close gaps.
- Serve as manufacturing SME, identifying risks and mitigation strategies related to process steps, raw materials, and product performance.
- Collaborate with engineering, assay development, manufacturing and supply chain teams for inventory management and prototype supply.
- Establish and maintain manufacturing controls and documentation, including SOPs, work instructions, acceptance plans, and compliance with ISO 13485 and cGMP.
- Plan and execute validation protocols (IQ, OQ, PQ) and support procurement, installation, qualification, and maintenance of equipment.
- Perform root cause analysis for manufacturing failures and implement process improvements.
- Proactively identify and drive opportunities for continuous improvement in manufacturing operations.
Requirements
- 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.
- 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.
- Excellent communication skills and sharp attention to detail.
- Highly organized with a proactive, solutions-oriented approach.
- Bonus: Six Sigma and/or Lean certification, high-volume automated assembly experience, project management experience and leadership of project teams.
