Process Engineer

Lynx Recruitment Ltd
Bexleyheath
2 months ago
Applications closed

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PROCESS ENGINEER

Process Engineer

Process Engineer

Process Engineer

Process Engineer

Process Engineer

About the Role

We are seeking an experienced Process Engineer to join our innovative MedTech company on a 12-month fixed-term contract. Specialising in cutting-edge orthopaedic products, we are at the forefront of medical device manufacturing, utilising advanced laser-based additive manufacturing technologies to deliver life-changing solutions to patients.

This is a remote position offering flexibility while working with a dedicated team committed to excellence in medical device development and manufacturing.

Key Responsibilities

* Lead and support process validation activities across manufacturing operations, ensuring compliance with ISO 13485 and FDA CFR requirements

* Develop, implement, and maintain robust manufacturing processes for orthopaedic medical devices using laser-based additive manufacturing technologies

* Conduct Process Failure Mode and Effects Analysis (PFMEA) in accordance with ISO 14971 risk management standards

* Drive continuous improvement initiatives to optimise process efficiency, quality, and compliance

* Collaborate with Quality Assurance, Regulatory Affairs, and R&D teams to ensure seamless product development and commercial manufacturing

* Prepare and maintain comprehensive process documentation, including validation protocols, reports, and standard operating procedures

* Support investigations and implement corrective and preventive actions (CAPA) for process-related non-confor...

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