Device Engineer

🧬 **Device Equipment Engineer** 📍 Dublin, Ireland or Cambridge, UK 🕒 Permanent, hybrid with 3 days on-site, occasional travel between sites 🧠 Own device and equipment engineering from specification through to manufacturing 🧪 Drug delivery devices and combination products: injectables and inhalation 🏢 **Role Context** A global pharmaceutical company is strengthening its device development team with a senior engineer able to take drug delivery devices from concept to market. The organisation is building its own device platforms across injectable and inhaled products, with programmes spanning early development through on-market lifecycle. You will join a close engineering group working alongside co-located quality and regulatory colleagues. This is a hands-on technical ownership role where you will be given a scope and trusted to deliver it independently. 🎯 **What You Will Do** * Own assigned device and equipment workstreams from specification and supplier engagement through commissioning, qualification and transfer. * Perform engineering calculations, tolerance and structural analysis, FEA, statistics and material selection to support design decisions. * Translate product requirements into robust manufacturing processes, covering injection moulding, metal injection moulding, tooling and assembly lines. * Execute FAT, SAT, IQ, OQ and PQ activities, maintaining traceability from user requirements to site qualification. * Manage external suppliers, prototyping houses, CMOs and outsourced FEA and CFD specialists to deliver technical milestones. * Author and defend engineering documentation, risk assessments and change controls to regulatory standard. * Lead troubleshooting and investigations on equipment and manufacturing processes at partner and affiliate sites. * Collaborate with quality, regulatory, manufacturing and supply chain teams to deliver device programmes on time. ✅ **What We’re Looking For** * Degree or Masters in engineering, science or life science. * 5 to 10 years’ industry experience in medical device or pharmaceutical device development and manufacturing. * A track record of bringing drug delivery devices to market, ideally injectables, with inhalation also considered. * Strong grasp of product to process, including moulding, tooling, final assembly and equipment behaviour. * Working knowledge of design controls, GMP, 21 CFR 820, 21 CFR Part 4, Regulation EU 2017/745, ISO 13485 and ISO 14971. * Experience of FDA interactions and confidence defending technical calculations under regulatory scrutiny. * Strong analytical and problem-solving skills, including tolerance analysis, statistics and FEA. * Able to work independently with minimal direction and communicate clearly with internal and external partners.