Technologist Medical Device Winsford

Technologist (Medical Device) Winsford

I am currently recruiting for a Technologist to join a world leading independent developer and manufacturer based in Winsford.

Role responsibilities:

Reporting to the Sustaining Engineering Manager, you will be a key member of the team responsible for the implementation of new materials, processes, and product design changes that enhance performance, improve quality, ensure regulatory compliance, achieve cost reduction goals and/or maintain continuity of supply of advanced wound care medical device portfolio.

• To plan, execute and report on manufacturing trials using new materials, products, and processes.
• To plan, execute and report on routine and investigative laboratory testing.
• Adopt & influence adoption of high standards of GDP, GLP, GMP & Health & Safety in the laboratory, manufacturing areas and offices.
• To author and review technical documentation in line with project requirements and in accordance with all applicable medical device regulations (MDD, MDR, FDA, CRF Part 8.20., ISO 13485, GxP)
• To support change control and regulatory change submissions.
• Actively contribute to departmental meetings and forums and contribute to the systematic improvement of the department in a positive, pragmatic, and enthusiastic manner.
• To support NC's, CAPA's from a technical perspective, conducting root cause analysis using recognised problem-solving, and quality improvement tools and techniques.
• To support design control activities, including authoring, reviewing, and updating design inputs, outputs, design verification, design validation, design transfers, design reviews, as required.

Role requirements:

• Educated to degree level in a scientific discipline or engineering related field
• Able to work collaboratively and effectively with colleagues
• Driven to achieve results
• Strong statistical and analytical skills
• Strong practical problem-solving skills
• Strong organisational and communication skills
• Good knowledge of H&S, Quality and Regulatory compliance requirements.
• Experience of working in the Medical Device Industry in a technical capacity is preferable.