WALKER COLE INTERNATIONAL LTD

3 job(s) at WALKER COLE INTERNATIONAL LTD

WALKER COLE INTERNATIONAL LTD
Oct 08, 2025
Full time
A leading medical device innovator based in South Wales is currently searching for a Senior Electronics Engineer to join their technical team. This is a multi-national organisation with a large portfolio of devices sold globally. As a Senior Electronics Engineer, you will play a key role in the design and development of safety-critical electronic systems that power next-generation medical devices used in hospitals and healthcare settings worldwide. You ll work closely with cross-functional teams to take concepts from design through to market, ensuring performance, compliance, and patient safety at every step. Your responsibilities as the Senior Electronics Engineer will include: Leading the design of electronic systems for medical devices, ensuring safe operation in conjunction with embedded software platforms Selecting and sourcing components, and integrating electronics into embedded software environments Creating and maintaining design documentation including DFMEA and technical files Supporting system verification, validation, and risk assessments including cybersecurity Recording all engineering activity in product lifecycle management (PLM) systems and supporting legacy systems when required Ensuring compliance with ISO 13485, IEC 60601, ISO 14971, ISO 62304, and relevant FDA standards To be successful as the Senior Electronics Engineer, you will need to demonstrate: A degree in Electronic Engineering or similar technical field Proven experience in electronics design across the full product lifecycle In-depth knowledge of analogue and digital circuit design for embedded systems Strong debugging and problem-solving skills in hardware/software integration Familiarity with safety-critical and regulated environments, especially medical devices In addition, the following will be advantageous for a Senior Electronics Engineer: Understanding of embedded software (C/C++, RTOS, Linux/Android) Experience with cybersecurity threat modelling Experience working with lab equipment and test/validation procedures Knowledge of PLM systems and regulatory submission documentation Senior Electronics Engineer Medical Devices Embedded Systems IEC 60601 ISO 13485 Electronics Design Analogue and Digital Circuits Hardware Engineer PLM Medical Device Engineering Cybersecurity Embedded Hardware South Wales Engineering Jobs
WALKER COLE INTERNATIONAL LTD
Oct 06, 2025
Full time
Walker Cole International is searching for a Senior R&D Scientist - E&L and Nitrosamine Method Development - to join a global pharmaceutical company at their R&D and GMP-regulated site in the UK. As the Senior Scientist, you will play a key role in developing and validating analytical methods to support Extractables, Leachables, and Nitrosamine testing across pharmaceutical products and materials. Your responsibilities will include: Leading and supporting risk assessments and analytical method development for E&L and Nitrosamines. Developing, validating, and transferring LC-MS and GC-MS methods in compliance with GMP and regulatory guidelines. Performing data interpretation, troubleshooting, and technical investigations to resolve analytical issues. Preparing technical reports and regulatory documentation to support product filings and submissions. Collaborating with QC, QA, and Regulatory Affairs teams to ensure analytical compliance and product quality. Contributing to continuous improvement within analytical R&D and supporting method optimisation projects. To be successful, you will have: Proven experience in Extractables & Leachables and/or Nitrosamine analysis within a GMP-regulated laboratory. Hands-on experience with LC-MS or GC-MS and method validation techniques. Strong problem-solving, communication, and documentation skills. Analytical Chemistry Extractables & Leachables Nitrosamines LC-MS GC-MS Method Development Validation GMP Pharmaceuticals R&D
WALKER COLE INTERNATIONAL LTD
Oct 03, 2025
Contractor
Walker Cole International is searching for a Process Technician to join a global pharmaceutical manufacturing business at their high-volume, GMP-regulated production site in Cambridgeshire. As the Process Technician, your responsibilities will include: Operating and monitoring pharmaceutical manufacturing equipment in compliance with GMP, safety, and environmental regulations. Carrying out raw material charging, basic equipment maintenance, and cleaning procedures to support batch production. Maintaining accurate production records and reporting any deviations or quality issues. Supporting investigations, process improvements, and updates to Standard Operating Procedures (SOPs). Collaborating with cross-functional teams and adapting to changing operational needs across multiple production areas. To be successful as the Process Technician, you will have: Experience in a GMP-regulated or manufacturing environment (pharmaceuticals or chemical manufacturing preferred). Strong attention to detail, communication, and observational skills. A proactive, team-oriented approach with the flexibility to work across different production zones. Willingness to learn and contribute to continuous improvement initiatives. A strong standard of written English and basic numeracy for documentation and reporting. Manufacturing Technician Process Operator GMP Pharmaceutical Production Cleanroom Regulated Manufacturing