Hands-on, results-oriented Automation & Process Engineering Manager to lead the design, procurement, integration, and validation of automated manufacturing solutions for our medical device production lines.
This role will be responsible for translating manual processes into efficient, validated automated systems, working closely with cross-functional teams and external equipment vendors to deliver projects on time, within budget, and compliant with all applicable medical manufacturing standards.
Automation Strategy & Implementation
•  Analyze existing manual production processes, identify automation opportunities, and develop project roadmaps.
•  Lead the specification, selection, and integration of automated equipment, including part sorting, assembly, and precision cutting systems.
•  Oversee proof-of-concept testing and vendor trials to validate feasibility.
Project & Vendor Management
•  Prepare and manage RFQs (Requests for Quotation) for automation projects.
•  Coordinate vendor evaluations, selection, and contract negotiation.
•  Manage timelines, budgets, and deliverables for multiple concurrent automation projects.
Engineering Design & Integration
•  Develop technical specifications for automation equipment, including process parameters, tolerances, and throughput requirements.
•  Ensure seamless integration of automation solutions into existing manufacturing workflows and facilities.
•  Collaborate with maintenance and operations teams to develop preventive maintenance and troubleshooting protocols.

Compliance & Validation
•  Ensure all automation equipment meets FDA, ISO 13485, and applicable regulatory standards.
•  Lead IQ/OQ/PQ validation processes for new equipment.
•  Maintain documentation for traceability, change control, and quality audits.
Training & Knowledge Transfer
•  Develop training materials and SOPs for operators and maintenance personnel.
•  Provide ongoing support to production teams to ensure effective of automation systems.

Arcmed

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