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.
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your resume and details on file so when we see similar roles or see skillsets that drive growth in organizations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your resume so you can be considered for roles that have yet to be created.
Yes, we help with CV and interview preparation. From customized support on how to optimize your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.