Process Engineer

We are seeking a practical, talented Process Engineer to play a key role in the development, improvement and scale-up of a robust production system for our novel medical device.

Initially, you will support an ongoing design transfer to manufacture project. Following this, you will ensure the development, implementation and maintenance of manufacturing processes while adhering to ISO 13485 quality standards.

• Conduct and report on process validations: IQ, OQ and PQ.
• Collaborate with cross-functional teams to analyse and enhance manufacturing, assembly and QC processes.
• Lead the CPI programme to identify and implement appropriate strategies and solutions for process optimisation, cost reduction and efficiency improvement.
• Develop and maintain process documentation including standard operating procedures (SOPs), manufacturing work instructions and process flowcharts.
• Assist with Design for Manufacture (DFM) for continuous improvement.
• Manage/supervise relationships within our supply chain.
• Identify, evaluate and monitor potential international supply chain partners.
• Devise and conduct training programs with production partners on production processes and quality procedures.

• Maintain an effective quality management system compliant to ISO 13485 and 21 CFR Part 820.
• Perform risk assessments, root cause analyses and corrective/preventive actions (CAPA) to address quality issues and non-conformances.
• Drive continuous improvement initiatives to enhance product quality, reduce defects and increase customer satisfaction.

• Bachelor's degree in Engineering or a related field (e.g. Mechanical, Industrial, Biomedical Engineering).
• 3+ years of experience in process engineering, quality engineering or a related role within the medical device industry.
• Hands-on experience of process validation (IQ, OQ and PQ).
• Strong knowledge of quality management systems, regulatory requirements (e.g. ISO 13485, FDA) and standards relevant to medical devices.
• Proficiency in using quality tools such as Failure Modes and Effects Analysis (FMEA), Statistical Process Control (SPC) and Root Cause Analysis (RCA).
• Experience with process validation, statistical analysis and problem-solving methodologies.
• Hands-on experience in a variety of industrial manufacturing processes.

• Competitive salary & equity options.
• Hybrid working model with flexible hours.
• International travel opportunities.
• Opportunity to contribute significantly to the development and implementation of a lifesaving medical device.
• Exposure to a dynamic start-up environment that values innovation and collaboration.
• Mentorship from experienced engineers and the chance to grow your skills and career.
• Definitive pathway for progression within the company.