Automation Engineer

Summary

We're looking for a hands‑on Automation Engineer to design, deliver, and validate custom (non-off‑the‑shelf) assembly and inspection automation for medical devices. You'll own solutions end‑to‑end-from requirements and concepting through commissioning, validation (IQ/OQ/PQ), and handover-while partnering closely with manufacturing, quality, suppliers, and wider business stakeholders. Light project management responsibilities are included (plans, budgets, and status to stakeholders).

Key Responsibilities

Solution Design & Delivery

• Translate URS/PRS into bespoke automation concepts (assembly and inline/offline inspection) and detailed designs (FDS/HDS/SDS).
• Select and integrate components: PLCs, motion, robotics, feeders, conveyors, tooling/fixtures, vision systems (measurement, presence/absence, cosmetic defect), sensors, pneumatics, and safety systems.
• Develop control logic, HMI screens, and data interfaces (e.g., MES/ERP, SCADA, historians).
• Lead FAT/SAT, site installation, commissioning, and ramp‑up to rate/quality targets.
• Drive DfM/DfA improvements and mistake‑proofing (poka‑yoke) for yield, throughput, and ergonomics.

Validation & Compliance (Medical Devices)

• Create and execute validation deliverables: risk management, traceability, IQ/OQ/PQ, test protocols/reports, and change controls.
• Ensure compliance with ISO 13485, 21 CFR Part 820/Part 11, ISO 14971 risk management, and GAMP 5 CSV principles.
• Author and maintain SOPs, work instructions, and technical files for audits.

Project & Stakeholder Management

• Own schedules, budgets, and RACI; maintain RAID logs; run design and readiness reviews.
• Manage vendor RFQs, SOWs, and performance for custom machinery integrators and component suppliers.
• Communicate status, risks, and mitigations to manufacturing, quality, supply chain, and leadership.

Continuous Improvement

• Lead root cause analysis (5‑Whys, Fishbone, DOE) and close CAPAs.
• Use Lean/Six Sigma tools to improve OEE, cycle time, yield, and first‑pass quality.
• Standardise machine modules and software templates to reduce engineering lead time.