Are you an experienced Engineer ready to bridge the gap between diagnostic concepts and high-volume manufacturing? Join our client in Livingston as a Product Development Engineer. In their fast-paced, ISO 13485 environment, you ll be designing components mechanically, electrically and chemically for our international customers. Are you ready to test your capabilities further? Key Responsibilities Technical Design and DFM: Develop solutions for complex challenges, ensuring all designs are optimized for Design for Manufacture (DFM) using robotics, laser ablation, and chemistry deposition. Project Management: Manage multiple client contracts simultaneously, generating technical specifications, protocols, and detailed reports. NPI and Validation: Execute technical feasibility experiments and oversee the validation of new products and processes (IQ/OQ/PQ) for introduction into manufacturing. Data Analysis: Perform rigorous statistical analysis on experimental data using Minitab to drive design decisions and process improvements. Compliance and Communication: Ensure strict adherence to ISO 13485 and 21 CFR Part 820, while effectively communicating technical milestones to clients and internal teams. Skills, Knowledge, and Experience Essential: Education: Degree in a technical or engineering discipline. Experience: Demonstrable, considerable experience in a similar product development role within a regulated manufacturing environment. Software Proficiency: Skilled in Solidworks (3