TEs Medical business unit, part of the Industrial Solutions segment, offers medical device OEMs, a complete product offering, and capability portfolio for minimally invasive, imaging, surgical, diagnostic, and therapeutic devices. With more than 350 design engineers and a global presence in all key medical device hubs, we are a premier partner to the worlds leading medical technology companies for their next-generation medical devices. We are experts in all aspects of device design and manufacture, from access & delivery solutions for interventional medicine; to sensors & connectors for surgical applications. Our innovative solutions enable ground breaking medical therapies such as treating heart disease without opening the body, placing microscopic devices into brain arteries and powering robotic surgery.
- Generate validation documentation (URS, IQ, OQ, PQ and process characterization studies & validation reports) and assist in the execution of protocols for equipment, process, utilities, methods and computerised systems.
- Generate collection plans for the qualification and acceptance of incoming components including product sub-assemblies.
- Troubleshoot validation issues associated with the validation project and provide feedback to the product/process design team.
- Ensure consistency on validation/qualification approach across systems and projects. Review and approve changes to equipment, process, utilities, methods and computerised systems to ensure the validation status of equipment is maintained.
- Ensure validation documents are up-to-date (primarily project MVPs and key inputs).
- Manage the execution of the product/process validation as per the MVP and project plan.
- Work directly with customer validation representatives to define inputs and requirements to the MVP.
- Ensure all results and data are correct and follow-up on any gaps or discrepancies.
- Liaise with the Engineering function to ensure that equipment validation requirements are maintained from Purchase to Qualification of new technology equipment.
- Provide guidance and direction in the preparation and execution of validation activities, including carrying out training to staff across various functions.
- Maintain validation procedures and templates up to date, focusing on continuous improvement.
- Degree in Science/Engineering with 3 years experience in a similar role within the Medical Devices or related Healthcare industry.
- Strong knowledge of ISO and FDA quality requirements.
- Good understanding of validation concepts and documentation.
- Strong communication skills, including ability to advise and influence.
- Excellent attention to detail and report-writing ability
- Proven ability to work on own initiative.
- Highly organized with strong ability to prioritize tasks.
- A general knowledge and experience of statistical analysis methods is an advantage.