Global R&D - TechnologyHardwear NPI Technology and HipRaynham, USThe purposeThe key purpose of the Development Engineer role is developing NPI (New Product Introduction) medical technology devices, hardware and instrumentation for the hip and knee implants. The focus is on the development of robotic technologies integrated with the Corin Ecosystem. Additionally, the engineer will support already commercialized products by Corin Group through design optimization and maintenance.
The key responsibilities of the Development Engineer- Create the necessary design documentation to current SOP's and design procedures.
- Make structural calculations, perform tolerance stack analysis and assess CAD assembly.
- Validate and verify to support the development process.
- Create and maintain design and manufacturing documentation for robotic technologies, instrumentation and hardware
- Create and maintain 3D and 2D CAD drawings and models for design and manufacturing use.
- Manage specific design projects as and when required, to budgets and plans.
- Lead and participate in project core teams, liaising with QA, RA, Clinical, R&D, Manufacturing, and Production Engineering as part of CAPA, continuous improvement, and optimization projects.
- Critical review and updating of Design History File (DHF) and risk management documentation.
- Provide design and process support to Corin departments, sub-contractors, and customers.
- Produce test protocols and reports to support performance testing of Corin instruments and implant devices.
- Adhere to Quality Management System (QMS) requirements in line with Corin's ISO13485 QMS & Good Manufacturing Practice (GMP) FDA21 CFR Part 820
- Ensure that process & timeline requirements for Corrective & Preventive Actions (CAPA) are met following Corin's Standard Operating Procedures (SOPs) and support of Corin's Global Objectives for CAPA
The ideal Development Engineer will have/be- An advanced Apprenticeship or University degree in relevant subjects such as Mechanical Engineering, Biomedical Engineering, Product Design, or equivalent experience.
- A competent CAD operator, with experience with Siemens NX and/or SolidWorks would be an advantage.
- Computer literacy.
- Good communication skills
- Previous work experience in a regulated industry, preferably medical devices.
- Knowledge of manufacturing processes and inspection methodology.
- Knowledge of the CAPA process and associated problem-solving techniques.
The specific pay offered may be influenced by a variety of factors, including the candidate's experience, education, and skill set.
IND007
