Principal Device Development Engineer - Hertfordshire
SRG are partnering with a global science company that are looking to expand their patient centric medical devices, drug delivery team. Based in their site in Hertfordshire, they are offering a hybrid approach to increase the scope of talent. Offering a highly competitive salary and benefits package. Responsibilities:* Lead device development work streams for R&D product development.
* Work across platform devices, co-ordinating development activities and managing platform documentation.
* Collaborate with multi-disciplinary teams across GSK and international sub-contractors.
* Manage user, design or process risk assessments.
* Co-ordinate testing activities (e.g. verification, validation, Design of Experiments, robustness studies) to ensure device safety and performance.
* Lead and participate in design reviews at critical stages of device development and device development project team meetings.
* Use problem solving skills and utilisation of different strategies to support resolution of design, manufacturing, and regulatory challenges.
* Accountable for the compilation of device development documentation including Design History Files and Risk Management Files.
* Work closely with the manufacturing organisation to ensure that methods and processes are transferred successfully for commercial production.Requirements:
* 1st or 2:1 in Mechanical Engineering, Biomedical Engineering, or related degree. * Experience of medical device or combination product development.* Ability to project manage effectively to meet deliverables.* Strong understanding and experience of working within device regulatory requirements and industry processes such as design controls, risk management, QMS, and GMP.
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