Product Development Engineer II

Description

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 & 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 & 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 & 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 (3D), Draftsight (2D), AlphaCAM, and Minitab. Technical Knowledge: Fully versed in modern manufacturing equipment (lasers, robotics, liquid dispensing) and metrology tools (CMM, contact angle). Regulatory Knowledge: Deep understanding of ISO 13485 and 21 CFR Part 820. Leadership: Experience leading work packages and supporting less experienced colleagues. Desirable:

Working knowledge of biosensor design and surface modification techniques. Six Sigma Green or Black Belt qualification. Environment & Culture

Our client is an established, vibrant, and rapidly changing organization. This role offers high autonomy, variety, and the opportunity to make a significant impact on innovative diagnostic technologies.

Ad ID: 5417947691