Education: Bachelor's /Master's degree in Engineering.
Experience: A minimum of five years’ experience in manufacturing engineering working directly on a production floor leading the resolution of manufacturing engineering problems.
Lead manufacturing fixture/process development on complex manufacturing equipment.
Firm understanding of IQ, OQ, PQ and Software Validation requirements.
Maintain manufacturing specifications, requirements, and Process Failure Modes and Effects Analyses (PFEMA) in accordance with protocols and FDA guidance documents. Conduct and lead failure investigations and root cause analysis.
Experience with Lean manufacturing, continuous improvement and New Product Introductions.
Must have very strong interpersonal, communication and teamwork skills.
Green belt/black belt certification is a plus.