Project Engineer, Quality Engineering

Project Engineer

Spectra Medical Devices, LLC, Thornaby Stockton-on-Tees, England, United Kingdom

Elevaris Medical Devices is a Contract Development and Manufacturing Organization for industry-leading, multinational healthcare companies, global Original Equipment Manufacturers, and emerging technology companies. It is one of the world's leading manufacturers of made‑to‑spec procedural needles and specializes in the manufacture of precision micro‑components, complex tubular components, and sub‑assemblies for the medical device industry. The company also distributes a wide range of complementary pharmaceutical products, surgical instruments, and medical supplies.

A new era of precision medical device development and manufacturing capabilities.

Founded in 1995, Elevaris was previously known as Spectra Medical Devices. Following acquisition of UK‑based XL Precision Technologies, the company rebranded to Elevaris Medical Devices.

To provide comprehensive engineering and project support across the full lifecycle of development and pre‑production (NPI) projects. This role ensures the successful planning, coordination, and execution of technical activities, including RFQ processing, cost analysis, feasibility assessments, and client engagement. The Project Engineer will play a key role in managing BOMs, procurement processes, and validation documentation, while collaborating with cross‑functional teams to deliver projects on time, within budget, and to customer specifications.

The position also supports continuous improvement by developing project methodologies and ensuring compliance with quality and validation standards.

• Project support of development and pre‑production (NPI) projects including but not limited to:
• RFQ processing
• Material costings
• Cost card completion for commercial review
• Preparing, scheduling, coordinating, and monitoring of assigned engineering projects
• Interaction with clients, interpreting their needs and requirements; acknowledgement and agreement of their orders/vision
• BOM creation / management / maintenance
• Developing specifications for the project’s needed equipment such as machine allocation / timing plans to satisfy customer project demands
• Co‑operating and communicating with the project manager and other project participants and collaborating with senior engineers to create more efficient project methods and maintain the project’s profitability
• Reviewing the engineering tasks and initiating the necessary corrective actions
• Creating frameworks to measure the project’s metrics and data collection
• Project Specific requirements:
• Process Flow Diagrams
• FMEA
• Validation protocols and plans
• Custom specific PPAP

Where necessary additional developmental support and training will be available to support you in this role.