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Medical Device Design Engineer

1 month ago

Cardiff, Cardiff, United Kingdom ATL Technology Full time

Job Summary

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

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).
  • Adhere to the standards of behaviours, policies and procedures as laid out in the employee handbook.
  • All other essential related duties and responsibilities as required.

Requirements

Education / Qualifications:

Bachelor's degree in an appropriate Engineering discipline or equivalent real job experience

Certified SolidWorks Expert (CSWE) or Professional (CSWP) qualification; highly desirable.

Behaviours / Skills / Experience:

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

What you should know about us:

ATL Technology is a fast-growing provider of outsourced design, development and manufacturing services to the medical device market, and its UK site (GML Medical Ltd - an ATL Technology owned Company) is based in St Mellons, Cardiff, UK.

We believe there is a better way to bring medical devices to market. We use an engineer-to-engineer approach to develop custom interconnect solutions for medical devices that improve the quality of one's life'. It is our mission to be the leading provider of custom engineered solutions for top medical device manufacturers.

ATL has operations in the UK, China, Costa Rica, Taiwan, UT-USA, plus remote staff in strategic global locations and we're growing

Other information

You will be required to provide evidence of your eligibility to work and reside in the UK, in accordance with the requirements of Section 15 of the Immigration, Asylum and Nationality Act 2006. The role that you are applying for may require you to undertake a basic/standard/enhanced Disclosure & Barring Service (DBS) check.

At Gyrus Medical Ltd (An ATL Technology Company), we have a dedicated in-house recruitment team that cover all areas of the business. As a backup, we have a preferred supplier list (PSL) of vetted suppliers and as such, are unable to accept unsolicited CVs from recruitment agencies or search firms outside of our PSL (which is now closed to new suppliers). Please note that Gyrus or ATL will not be responsible for any fees, charges or terms associated with any such CVs. CVs will only be accepted from approved agencies where terms and conditions have been agreed and we have instructed them to work on specific positions. Agencies will be contacted by the recruitment team should we wish to engage their services. We do not take sales calls and politely request that you refrain from directly approaching the recruitment team or line managers and remove Gyrus Medical Ltd from your mailing list. Thank you for your understanding.

Gyrus Medical Ltd (an ATL Technology Company) is an equal opportunity employer.