About the Company - Corin is seeking a biomedical engineering graduate to join us as a Design/Development Engineer to develop Corin's existing implant and instrument products to ensure they are sustainable in the market and to optimise design optimisation. This role is based in Cirencester, at our global head office where we manufacture our hip and knee implants for worldwide distribution, so how exciting is it that as a Design Engineer you get to see your re-designed product going into production!!! We will require you, therefore to be onsite 3-4 days a week as you will be collaborating with the manufacturing site, engineers and other key areas of the business.
About the Role - The ideal Design Engineer / Development Engineer will have/be A Biomedical Engineering, Mechanical Engineering, Product Design, or equivalent degree experience. Studied and have a strong understanding of, or completed some work experience in an orthopaedic area - hip or knee knowledge is highly beneficial. Competent CAD operator, experience with Siemens NX and/or Solid Edge would be an advantage. Previous work experience in a regulated industry, preferably medical devices. Knowledge of manufacturing processes and inspection methodology. Knowledge of CAPA process and associated problem-solving techniques. Excellent teamwork and collaboration skills. Computer literacy. Good communication skills.
Responsibilities - Create and maintain 3D and 2D CAD drawings and models for design and manufacturing use. Contribute to the design and development of new implant and instrument products in compliance with standard operating procedures and best practice. Perform structural calculations, tolerance stack analysis, and CAD assembly assessments. Validate and verify activities to support the development process. Create and maintain design documentation for instrument and implant devices. Create the necessary design documentation to current SOP's and design procedures. Manage specific design projects as and when required, to budgets and plans. Lead and participate in project core teams, liaising with other functions in the business such as quality assurance, quality control and regulatory affairs, Manufacturing and Production Engineering, as part of CAPA, continuous improvement, and optimisation 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. Assist post-market activities in complaint investigations, root cause analysis, and defect resolution. Support regulatory submissions and audits, including FDA submissions and CE marking (MDR). 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 by Corin's Standard Operating Procedures (SOPs) and in support of Corin's Global Objectives for CAPA.
Required Skills
* Studied and have a strong understanding of or completed some work experience in an orthopaedic area - hip or knee knowledge is highly beneficial
* Competent CAD operator, experience with Siemens NX and/or Solid Edge
* Previous work experience in a regulated industry, preferably medical device
* Knowledge of manufacturing processes and inspection methodology
* Knowledge of CAPA process and associated problem-solving techniques
* Excellent teamwork and collaboration skills
* Computer literacy
* Good communication skills
Pay range and compensation package - Corin offers great benefits, including a starting salary of £28,000 - £32,000 (depending on experience) and a discretionary annualised salary. Pension starts at 6%, rising to 9.7% after 18 months if you contribute 4%. Life assurance 6x basic salary. BUPA medical insurance. Free car parking and electric charging points. A great subsidised canteen. A great place to learn and grow your orthopaedic career