Closing Date: 21st February 2024
Project/Development Engineer - EssexOverall PurposeUndertake projects ranging in scope from development of new devices and line extensions to supplier changes and engineering drawing refinements. Update and maintain associated technical documentation to ensure compliance to internal procedures and applicable regulations and standards.
Key Tasks Undertake engineering change requests to maintain the competitiveness of the company's device portfolio and ensure reliable supply of products to the end user. The change requests may include:o Development of new devices to enhance the device portfolio.o Implementation of line extensions, such as additional implant variants within an existing product range.o Supplier changes to dual source existing supply.o Packaging and labelling changes to ensure ongoing compliance to regulations and standards.o Drawing and tolerance refinements to facilitate repeatable and reproducible device inspection and ensure manufacturability.o Manufacturing process changes. Formal documentation and impact assessment of change requests in accordance with company procedures. Update / creation of parametric CAD models, engineering drawings, and inspection plans in Siemens NX and Teamcentre. Maintenance of design specifications including packaging and labelling specifications, QC checklists, and First Article Inspection (FAI) plans. Input into the evaluation and selection of subcontract manufacturers and provide technical and product specific expertise in the subsequent design transfer activities. Complete technical reviews with the subcontractor to implement design for manufacture and assembly. Planning and execution of design verification and validation activities to ensure that the design has fulfilled the design input requirements, and to validate the device against the user needs. Verification / validation activities may include tolerance analysis, mechanical testing, simulated use validation, software validation, process validation, cleaning, packaging, and sterilisation validations, ISO 10993 biological safety evaluation. Creation of test protocols and reports, and management of external test vendors and specialists, as required. Participate in formal design reviews to ensure that all requirements are fulfilled at each project phase, and to identify any potential problems. Update / creation of associated technical documentation, which may include:o Device Master Record / Medical Device File.o Design History File / Design and Development File.o Risk Management File.o Technical Files.o Process Validation Master Plan and Summary Report. Support FDA site inspections and Notified Body audits for QMS, microbiology, and technical files as part of the technical team. Provide technical expertise and support to other functions in the business including sales and marketing, QARA, loaner, and inspection.Knowledge, Skills, and Experience A degree in engineering, or similar technical field, and experience in an engineering role in medical devices. High proficiency with 3D parametric CAD modelling and engineering drawings according to ASME Y14.5. Experience with Siemens NX would be particularly desirable. A working knowledge of ISO 13485 and 21 CFR 820 Quality System requirements, and ISO 14971 risk management. Ideally, a highly driven and proactive person who can work in a dynamic and fast paced team. Ability to work on multiple concurrent projects under pressure. A working knowledge of the manufacturing processes used for orthopaedic devices would be highly desirable.
Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.