Job Description
About us:
Founded on the grounds of innovation – iXceed Solutions, is an ISO certified, leader in Talent and Digital recruitment solutions, serving fortune 100 companies globally.
We have many global accolades to our credit – UK Enterprise Awards - HR Tech Startup of the year- Europe - 2022, UK IT Awards - Leading Talent & Digital Solutions of the Year 2022, Titan Awards-Entrepreneur of the Year -2023, Asia fastest growing HR tech companies in 2023, Iconic Brand of the Year in Staffing & Recruitment 2023, Top 4 The Most prominent Talent solutions firm to work with in 2024, Hottest HR Tech Startup by Business World, The Greatest Brands & Leaders Asia & GCC -2020 -2021 by AsiaOne and many more.
Website: www.ixceed-solutions.co.uk
LinkedIn URL: https://www.linkedin.com/company/ixceed-solutions
The role:
Role: Mechanical Engineer
Location: Olympus UK
Type: Contract insideIR35
Task
* Provide support to products post launch, coordinating design and manufacturing changes and improvements to meet defined specifications (esp. device and manufacturing requirements) as part of life cycle management (changes, QIS, CAPA etc.) in cooperation with other specialist departments, taking into account medical application requirements and economic requirements. This applies to both in-house and purchased products and assemblies.
* The particular focus is on the mechanical design of the system and its components, taking into account the various non-mechanical subsystems.
* Maintain a strong and current understanding of relevant new product development and manufacturing technologies and their application to medical device design to meet or exceed customer, company and project needs
* Evaluation and documentation of the feasibility, reliability and risk of concepts and / or prototypes through engineering testing and analysis in order to demonstrate that the product performance, manufacturability, safety and cost are consistent with the customer, regulatory and production requirements
* Generate, modify and review design history file documentation in compliance with relevant regulatory requirements e.g. Quality System Regulations (QSR), Good Manufacturing Practice (GMP), International Standards Organisation (ISO) and in accordance with company development standards (e.g. PDD, TDP) throughout the product life cycle to ensure the design is fully documented
* Progress vendor activities in agreement with global sourcing relative to communication of specifications, development schedules and tracking in order to obtain components, supplies or equipment to support prototype or product procurement and assembly
* Deliver manufacturable designs acceptable to operations by applying design for manufacture principles, implement and communicate feedback from manufacturing engineers, external suppliers and other sources to the R&D engineer
Skills
* Bachelor’s or master’s degree in mechanical engineering or equivalent professional education
* 4+ years of professional experience
* Confident handling of mechanical design
* Experience with material compliance
* Knowledge of the process-orientated development of medical products is desirable
* Experience in the area of standardization and certification of medical devices (IEC 60601-1, ISO, EN).
* Experience in sustaining regulated devices under Design Control (21 CFR 820), ISO13485, ISO14791, MDR and knowledge of applicable regulations
* Good or better written and spoken English skills
* Strong collaboration skills