Manufacturing Engineer

A growing medical-device business is looking to engage an experienced Manufacturing Engineer on a freelance basis to support its manufacturing operations, process development and ongoing engineering activities.

This is an excellent opportunity to join a developing medical-device organisation where you will play an important role in improving manufacturing processes, supporting product industrialisation and ensuring products can be manufactured consistently, efficiently and in line with the relevant quality and regulatory requirements.

The engagement will initially be approximately 20 hours per week, with the flexibility to work fully remotely. As the business and workload develop, the requirement is expected to increase progressively towards full-time hours.

We are looking for someone with a strong engineering background and practical experience within the medical-device sector, ideally someone comfortable working autonomously and providing hands‑on technical support within a growing business.

• Support the development, implementation and optimisation of manufacturing processes for medical-device products.
• Review existing manufacturing methods and identify opportunities to improve efficiency, consistency, productivity and product quality.
• Develop and improve manufacturing procedures, work instructions, process documentation and standard operating procedures.
• Provide engineering input into new product introduction (NPI), product industrialisation and manufacturing readiness.
• Support the transition of products from design and development into repeatable manufacturing processes.
• Identify potential manufacturing risks and recommend practical engineering solutions.

• Support the development and execution of process validation activities, including IQ, OQ and PQ where applicable.
• Ensure manufacturing processes are developed and maintained in accordance with relevant medical-device quality standards and regulatory requirements.
• Work closely with Quality and Regulatory teams to support compliance with FDA requirements and ISO 13485.
• Assist with investigations into manufacturing issues, non-conformances and process deviations.
• Support root cause analysis and the implementation of corrective and preventive actions (CAPA).
• Contribute to process risk assessments, FMEAs and continuous improvement activities.

• Work alongside R&D, Product Development and Quality teams to ensure products are designed with manufacturability in mind.
• Provide Design for Manufacturability (DFM) input and identify opportunities to simplify or improve product design.
• Support engineering changes, design transfers and manufacturing documentation updates.
• Help resolve technical issues relating to product performance, materials, components and manufacturing methods.
• Assist with supplier and component-related engineering issues where required.
• Identify opportunities to reduce manufacturing costs, waste and process variation.
• Apply structured problem-solving and continuous improvement methodologies.
• Review manufacturing data and performance metrics to identify trends and areas for improvement.
• Recommend practical solutions to improve process reliability, repeatability and scalability.

• Proven experience as a Manufacturing Engineer, Process Engineer or similar engineering role within the medical-device industry
  .
• A strong understanding of medical-device manufacturing processes and engineering principles.
• Experience supporting manufacturing…