Location : Hybrid Department : R&D / Engineering Job Type: Full time Contract Type: Temporary Do you have a background in packaging and labelling engineering within sterile products? Have you proven experience in purchasing packaging equipment and associate validation in highly regulated industries? Looking for your next interim challenge? If so, we want to hear from you! Amber Therapeutics are looking for an experienced Packaging & Labelling Engineer to join our dynamic team as a contractor for 6 months. This is a full-time hybrid contracting role based at our new custom-built facility in Harwell, Oxfordshire, although we would consider 3 days per week for the right candidate. Amber is a pioneering neuromodulation company dedicated to transforming the lives of patients through advanced medical technology. We specialize in the development of cutting-edge active implantable medical devices. The Role You will lead and deliver labelling and packaging activities across the product development lifecycle for Amber’s neuromodulation systems, leading development, testing & process qualifications as required. Working closely with other functions (R&D, regulatory, human factors etc) you will ensure the solutions are effective, safe and user friendly whilst complying with regulatory requirements (FDA, EU MDR, UK regulations). Key Responsibilities: Lead packaging & labelling projects for both new product development and updates to existing devices. Develop and validate sterile and non-sterile packaging & labelling systems Design and install packaging production lines from procurement through to validation for medical devices. Map & execute required verification activities with internal & external parties. Optimise processes using tools like DFMEA, PFMEA, and DOE to improve packaging performance. Lead root cause investigations in packaging and labelling performance. Support production transfer, delivering training and ensuring smooth integration of packaging systems. Drive performance improvement within labelling & packaging across manufacturing metrics (cost, scrap, productivity and utilisation). Apply lean principles to streamline packaging line efficiency. Generate compliant labelling using appropriate tools (Loftware). Create documentation to capture packaging & labelling solutions to appropriate in-house standards (SOPs, work instructions, protocols) and regulatory submissions. Partner with production, engineering, quality & regulatory teams to align packaging & labelling solutions. Contribute to risk management and user interface design. Own user-related risk analysis within broader risk management framework. Oversee sterilisation subcontractors and collaborate on product validation activities. Represent packaging & labelling during audits and design reviews; approve key deliverables. Skills & Experience Essential: Engineering degree in Mechanical, Electrical, Mechatronics, Manufacturing, or similar discipline. Experience leading the design, development & qualification of packaging & labelling systems in regulated industries, including purchasing of packaging equipment and associated validation. Experience with packaging design for sterile products Desirable: Knowledge of Loftware labelling software. Familiarity with international regulatory bodies and clinical trial interface. This position is ideal for an experienced packaging & labelling engineer looking for a new exciting interim project with the opportunity to make a meaningful impact in the medical device industry. Your strong technical expertise and problem-solving skills will enable you to excel in working on complex, multi-disciplinary projects. This role requires excellent written and verbal communication skills to convey technical information with clarity and precision. You should have the ability to thrive in a fast-paced, collaborative environment, balancing independent contributions with teamwork to deliver innovative solutions in a dynamic, cross-disciplinary setting. About Us Amber Therapeutics is developing a closed-loop neuromodulation therapy able to treat mixed urinary incontinence for the first time and transform the clinical outcome of a very large untreated patient population. Amber’s fully implantable PicostimTM System targets the pudendal nerve with a device that can both stimulate and sense physiological responses. Please refer to our website for further information. What We Offer This is a chance to be part of a ground-breaking team creating life-changing therapies for millions of people globally. You join us at an exciting phase of our development, as we expand the team and accelerate towards our first Pivotal Trial. We look forward to hearing from you. REF-223306