Equipment Engineering Manager

About the role

The Manager, Equipment Engineering will build and lead a team responsible for the equipment lifecycle across Precision Neuroscience’s microfabrication and device assembly facility in Addison, Texas. This role supports Class III medical implant production and reports to the VP, General Manager.

Responsibilities

• Build, lead, and develop a small team of equipment engineers and technicians across front-end and back-end toolsets.
• Own equipment uptime metrics — availability, MTBF, MTTR — across the legacy mixed-toolset fleet.
• Establish and run routine, preventative, and corrective maintenance programs, balancing OEM service contracts with internal capability.
• Own spare parts strategy and inventory, including workflows for long-lead and obsolete OEM parts.
• Lead new equipment installations and qualifications — FAT, SAT, IQ/OQ, and production handoff.
• Serve as the technical escalation point on the hardest failure modes — particularly on legacy equipment — coaching the team through root-cause analysis and vendor evaluation.
• Partner cross-functionally with process engineering, R&D, facilities, EHS, and quality on operations and capital projects.
• Operate under QMS discipline for Class III medical implant manufacturing, supporting design transfer and production release.
• Drive operational discipline — documentation, change control, SPC — and grow the function as Precision scales.

Requirements

• Education + experience: BS in Engineering (Mechanical, Electrical, Materials, Chemical, or related) + 5–15 years equipment or fab engineering experience
• Minimum 2+ years of direct people management experience leading equipment engineers or technicians
• Demonstrated technical depth across the equipment lifecycle, including: Routine, preventative, and corrective maintenance program ownership in a fab or comparable manufacturing environment
• New equipment installation, IQ/OQ protocol execution, and production handoff
• Equipment uptime metrics ownership (OEE, MTBF, MTTR, or equivalent)
• Spare parts strategy and inventory management across critical tools

Preferred

• Working knowledge of front-end MEMS fabrication tools: photolithography, thin-film deposition (PECVD, HDPCVD, sputter, e-beam), plasma etching (ICP RIE), and wet processing.
• Working knowledge of back-end device assembly tools: thermal compression bonding, epoxy and silicone dispense, laser dicing, and mechanical saws.
• Direct experience in Class III or Class II medical device manufacturing under FDA QSR or ISO 13485.
• Experience operating a legacy fab or mixed-vintage toolset with limited OEM support.
• Leverage of Lean, Six Sigma, or equivalent operational excellence training; Green Belt or Black Belt a plus.
• Equipment qualification and calibration program ownership under FDA QMSR (21 CFR Part 820), with measurement traceability to NIST or international standards.
• Computer System Validation (CSV) experience for production equipment software per GAMP 5 and 21 CFR Part 11.

Skills, Knowledge and Expertise

• Education + experience: BS in Engineering (Mechanical, Electrical, Materials, Chemical, or related) + 5–15 years equipment or fab engineering experience
• Minimum 2+ years of direct people management experience leading equipment engineers or technicians
• Demonstrated technical depth across the equipment lifecycle, including: Routine, preventative, and corrective maintenance program ownership in a fab or comparable manufacturing environment
• New equipment installation, IQ/OQ protocol execution, and production handoff
• Equipment uptime metrics ownership (OEE, MTBF, MTTR, or equivalent)
• Spare parts strategy and inventory management across critical tools