Job Specification: Controls Engineer Medical Devices (Essex) Job Title: Controls Engineer Location: Essex (with occasional travel to UK/EU manufacturing partners) Employment Type: Full-time, Permanent Department: Automation & Controls / Manufacturing Engineering Overview Our client, a leading innovator in the medical devices sector, is seeking a highly capable Controls Engineer to support the development, automation, and optimisation of manufacturing equipment used to produce regulated medical technologies. The successful candidate will be responsible for designing and maintaining reliable, compliant, and high-precision control systems that operate within a GMP and ISO 13485 environment. Key Responsibilities Automation & Controls Development Design, develop, and validate PLC, HMI, and motion control systems for automated medical device manufacturing equipment. Produce and maintain Functional Design Specifications (FDS), control philosophies, URS, and validation documentation. Implement software solutions for precision assembly, testing, and packaging processes. Manufacturing Support Troubleshoot automation issues on production lines to minimise downtime and ensure product quality. Collaborate with production, quality, and process engineering teams to support continuous improvement. Lead control system upgrades and modifications in line with change control procedures. Compliance & Validation Ensure control systems comply with regulatory standards including ISO 13485, FDA CFR 21 Part 11, GMP, and relevant safety directives. Participate in IQ/OQ/PQ activities and support risk assessments (FMEA, PFMEA). Maintain validated states of control software and ensure robust documentation practices. Project Delivery Contribute to the full lifecycle of equipment projectsfrom concept and design through to FAT, SAT, commissioning, and handover. Liaise with external automation suppliers, integrators, and machine builders. Support new product introduction (NPI) activities requiring new or modified production equipment. Required Skills & Experience Technical Skills Proficiency in PLC programming (Siemens TIA Portal, Allen-Bradley, Mitsubishi, Beckhoff, or similar). Experience with HMI/SCADA systems and industrial communication protocols. Strong understanding of motion systems, robotics, sensors, machine vision, and precision control. Ability to interpret electrical schematics, pneumatic diagrams, and mechanical drawings. Industry Experience Experience in medical devices, pharmaceuticals, high-precision manufacturing, or similarly regulated industries. Familiarity with validation, traceability, and electronic records requirements. Professional Skills Strong analytical and problem-solving abilities, with a detail-oriented mindset. Excellent documentation skills and understanding of compliance-driven engineering. Ability to communicate effectively across cross-functional teams. Ability to manage multiple priorities in a fast-paced, regulated environment. Preferred Qualifications Degree, HNC, or HND in Electrical Engineering, Mechatronics, Automation, or related field. Experience working within ISO 13485, FDA, or GMP environments. Knowledge of functional safety (SIL, PL) and safety PLCs. Experience with machine vision systems (e.g., Cognex, Keyence) is a strong advantage. Whats on Offer Competitive salary and benefits package. Opportunities for professional development and training in advanced automation and regulatory standards. Exposure to cutting-edge medical manufacturing technology. A collaborative, mission-driven environment focused on improving patient outcomes.