Job 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.
