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Medical Device Design Engineer

1 month ago

Cardiff, Cardiff, United Kingdom ATL Technology Full time
Job Title: Medical Device Design Engineer

Job Summary:

We are seeking a highly skilled Medical Device Design Engineer to join our team at ATL Technology. As a Medical Device Design Engineer, you will be responsible for the production of designs and drawings of medical devices, mechanical components, jigs and fixtures, and any other technical drawing task.

Key Responsibilities:

- Develop detailed design drawings and specifications for product, electrical/mechanical equipment, jigs and fixtures, dies, tools, and controls, using computer-assisted drafting CAD software.
- Coordinate with and consult other Engineers to design, lay out or detail components and systems and to resolve design or manufacturing issues.
- Lay out and draw schematic, orthographic, or angle views to depict functional relationships of components, assemblies, systems, and machines.
- Drafting/collaborating on tolerance analysis with other engineers.
- Evaluate designs, drawings, and fabrication to company, industry, and customer standards.
- Produce and review product documentation (primarily drawing and specification documents).
- Manage change orders and implementation.
- Apply best practices in tolerancing and dimensioning.
- Provide measurement guidance and general knowledge of measurement system analysis.
- Creation of formal bill of materials and release through Product Lifecycle Management (PLM) system.
- Evaluate and document 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.
- Provide supervision and training for users of the 3D prototyping & printing facility.
- Monitor and maintain stock levels of 3D printing consumables.
- Travel both domestically and internationally, as needed.
- Work in accordance with Company Quality Standards, procedures and processes and comply with the requirements of Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).

Requirements:

- Bachelor's degree in an appropriate Engineering discipline or equivalent real job experience
- Certified SolidWorks Expert (CSWE) or Professional (CSWP) qualification; highly desirable.
- Ideally medical device design and/or development experience
- Good analytical, and mathematical skills
- Understanding of a wide range of engineering technologies used in design and manufacturing
- Knowledge of mechanical design relating particularly to mechanisms
- Knowledge of and ability to critique 2D engineering drawings and 3D modelling
- Good planning, organisation and control skills
- Experience of BS8888 and its related standards for technical product and engineering drawing presentation, capable of producing accurate and concise detailed drawings as needed for global component procurement
- Experienced in SolidWorks 3D CAD system for mechanical product design, capable of producing, analysing and optimising designs in a robust & time bound manner to realise the DFM & DFA requirements of the product
- Excellent verbal and written communication skills
- Ideally cGMP, ISO 13485, & FDA QSR knowledge as practiced in the disposable medical device industry
- Competent in MS Word, PowerPoint and Excel