Product Investigation Engineer

Job title:

Product Investigation Engineer

Location:

Witney
Job Type: 12-Month Contract

Working Hours:

40.25 hours per week
Salary: £23.37 per hour

We are seeking a Product Investigation Engineer to join our team in Witney. In this role, you will lead and execute root-cause failure investigations on returned medical device products-specifically blood glucose monitoring platforms, including meters, strips, and sensor technologies. You will play a pivotal role in ensuring regulatory compliance, driving product quality improvements, and collaborating with cross-functional teams such as R&D and Operations to eliminate failure modes on current and future on-market designs.

• Conducts all complaint investigation activities with regard to all blood glucose monitoring platforms (meter, strip and sensor technology) ensuring that the equipment is appropriately installed and maintained and that complaint investigations are completed according to procedures, in a timely manner, ensuring appropriate prioritisation. Be trained to investigate product from all ADC product lines
• Safely troubleshoot complaint returns to determine root causes (where possible) of failures using schematic diagrams and equipment such as soldering irons, drill presses, microscopes, oscilloscopes, software applications and other equipment while wearing appropriate protective equipment
• To be individually accountable for the quality and efficiency of their own actions whilst performing all steps of investigations on customer returned product in accordance with site and divisional procedures
• To visually inspect parts with the use of specified instruments for the purposes of performing measurements, defects and imperfections recognition; in accordance with the relevant procedures
• Operate manufacturing and basic laboratory equipment according to Standard Operating Procedures (SOPs)
• Meet division goals for timeliness of complaint investigations and identify opportunities for improvement and/or better efficiencies within the investigation processes/Trouble Shooting Guidelines. Lead wider improvements within the complaint investigation team. Pro-active in recommending improvements in terms of recommending cost savings through complaint process improvements and data quality, in line with Business Excellence initiatives
• Support the development and establishment of investigation procedures and troubleshooting methodologies for more complex failure modes on an engineering investigation basis that will lead to consistent investigations
• Demonstrates linkage or root cause to symptoms observed by customers and document symptoms and linkage to root cause of problems
• Translate engineering investigation methodologies into procedures which can be executed by the Complaint Handling Group and qualify new procedures/ equipment as necessary
• Develop metrics which demonstrate the effectiveness of the complaints investigation process
• Engage in effective written and verbal communications within the area and cross functionally including communicating trends and root cause information to Operations, R&D and other key stakeholders and recommend changes to eliminate root causes
• Keep up to date with the development of new products and through collaboration with peers within the complaints team and across the business, support activities required for complaint readiness prior to product launch including support for validation activities and post launch sustaining
• Decision making, working with the Line Manager and overseas business partners if appropriate, on any issues outside of routine problem solving
• Ensure area of responsibility is audit ready at all times and be the Subject Matter Expert for the area of responsibility to support audit situations
• Own the progression of any Exception Reports (ERs), CAPAs and Investigations within their area of responsibility
• Responsible for maintaining the effectiveness of the quality system at the site in accordance with divisional requirements and applicable regulations
• Perform verification of data & documentation reviews
• Input data accurately into software packages and perform queries on data
• Responsible for consistently maintaining a high standard of housekeeping in accordance with the principles of 6S
• To maintain good timekeeping for all tasks and to wear the correct working attire and PPE
• To know, understand and adhere to COSHH and EHS risk assessments applicable to the area, and to make sure that near misses and accidents are reported in a…