Our client is a medical technology company developing, manufacturing, and marketing smart connected diagnostics and diagnostic-led care solutions. Founded in 2014 by entrepreneurs with a successful track record in building and scaling medical diagnostics and health IT businesses, the company has major operations in the UK and the USA and is supported by a global sales network, they currently has over 600 employees worldwide.
They have recently launched an innovative Platform, and are looking for proactive, experienced, focused, and enthusiastic individuals who can make a significant contribution to the continued growth and success of their dynamic and forward-looking company.
Position is responsible for providing mechanical design, robust development and engineering expertise in the field of NPD (New Product Development), creating and developing designs, innovating using state of the art techniques to produce products which meet identified customer needs. Also, to carry out mechanical design development, analysis, and tooling development through to validation of final product for FDA submission and CE marking.
Key areas of responsibility
* Be aware of project timelines and contribute to the mechanical sections of the project plan with relevant tasks and estimated timescales.
* Concept Generation: contribute to the concept generation process by producing ideas to solve complex user/engineering issues
* Specification development: liaise within project teams to develop product specifications
* Design Development: Maintain ownership of the design through the development process and into production, when required. Will be comfortable and confident working in a broad range of production processes and materials
* CAD Development: Create, develop ideas and/or maintain designs using 3D CAD software (SolidWorks) in-line with the project key milestones and Quality System requirements
* FMEA & Risk Analysis: Participate or lead FMEA & RA activities through the full duration of a project, ensuring accurate documentation and successful conclusion of identified actions
* Tooling Development: Liaise with and manage tooling and prototype part suppliers in accordance with project milestones and complete acceptability assessments of trial components. Work with the quality team to deliver validated processes on production tooling
* Mechanical analysis: Use appropriate methods to perform mechanical analysis of designs to achieve robustness in operation and production in-line with end user needs and the quality plan
* Create robust characterisation and test methods to set tolerances and limits on key technical blocks of the instrument design.
* Verification/Traceability: Be able to maintain accurate and up to date records of all work carried out in accordance with the quality team/regulatory requirements. Write and execute test protocols and undertake development and verification testing
* Change & Configuration Control – Ensure change is managed effectively through development in accordance with the quality system
* The jobholder must be receptive to working in a fast-paced, constantly changing working environment that demands they step out of their comfort zone on a day-to-day basis
To be successful in this role you must be a highly motivated individual that can demonstrate flexibility and a can-do attitude. You must ensure positive, productive and proactive relationships with a range of internal and external key stakeholders and be self-driven, take ownership and demonstrate high levels of personal accountability.
* Degree qualified in a mechanical design engineering discipline or similar
* Proven track record of problem solving and innovation
* Ability to write clear and concise documentation
* Ability to manage external suppliers and technical partners
* Ensure records are completed in an accurate and timely manner
* Computer literacy and data analysis skills
* Knowledge and understanding iterative design optimization processes
* Experience of developing medical devices
* Familiarity with working under a Quality System
* Knowledge of validation and verification testing
* Demonstrable experience of production scale up, robustness and validation studies
* Familiarity with ISO:13485
* Hands-on knowledge in 3D CAD software like Solidworks or similar
Computer Aided Design
Solid Works (Cad)