Investigation Engineer - Medical Devices

We are the people who give possibilities purpose BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of Med Tech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

As a Complaints Investigation Engineer, you will play a key role in evaluating, investigating, and resolving customer complaints related to medical devices. You will perform technical investigations, root cause analyses, and product testing to determine complaint causes and support continuous product improvement. Working closely with cross-functional teams, you will ensure timely complaint resolution while maintaining compliance with regulatory requirements and quality management system standards.

• Manage the receipt, assessment, processing, and evaluation of complaint-related devices, components, and returned samples.
• Conduct thorough investigations into customer-reported product performance issues and adverse experiences.
• Perform technical troubleshooting, root cause analysis, and formal testing of infusion systems and associated medical devices.
• Accurately document investigation activities, findings, conclusions, and supporting evidence within the electronic complaint handling system.
• Analyse complaint data and trends to identify recurring issues, emerging risks, and opportunities for product and process improvements.
• Support health hazard assessments, reportability evaluations, and regulatory decision-making processes where required.
• Recommend and support implementation of corrective and preventive actions (CAPA) based on investigation outcomes.
• Collaborate with Engineering, Manufacturing, Quality, Regulatory Affairs, Service, and Product Development teams to resolve product issues.
• Ensure complaint investigations are completed within established timelines and in compliance with applicable regulatory requirements, company procedures, and quality standards.
• Prepare investigation summaries, technical reports, metrics, and periodic updates for management and cross-functional stakeholders.
• Contribute to continuous improvement initiatives aimed at enhancing complaint handling effectiveness and customer experience.
• Performing data execution and provide regular updates.

Degree in Electronic, Mechanical, Biomedical, or related Engineering discipline, or equivalent experience within the medical device, pharmaceutical, or regulated industry. Experience conducting technical investigations, failure analysis, and root cause identification for electromechanical products. Knowledge of complaint handling processes within a regulated environment, preferably medical devices. Familiarity with quality management systems and applicable regulations such as ISO 13485, MDR, FDA 21 CFR Part 820, and post-market surveillance requirements.

Strong analytical and problem-solving skills, with the ability to interpret technical data and draw evidence-based conclusions. Proficiency in Microsoft Office applications, data analysis, and technical report writing. Excellent attention to detail and ability to manage multiple investigations simultaneously. Strong written and verbal communication skills, with the ability to communicate technical findings to both technical and non-technical audiences. Self-motivated and capable of working both independently and collaboratively in a fast-paced environment.

£31 000 - £33 000 + benefits

To find purpose in the possibilities, we need people…