Product Development Engineer II

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.