Sustaining Engineer

2 weeks ago

Cardiff, United Kingdom Gyrus Medical Limited Full time
We are looking for a Sustaining Engineer to provide engineering input to ensure that changes required to released products to meet on-going business needs are conducted on time, within budget and with the required level of quality.

The successful applicant will:

  • Provide design and process development support to products post launch, coordinating design and manufacturing changes and improvements to meet defined device and manufacturing requirements
  • Accept the introduction of new products and ensure their efficient ongoing transition into regular production by appropriate provision of engineering services to operations and quality
  • Evaluate and document the feasibility, reliability and risk of changes to product designs and manufacturing processes.
  • Through engineering analysis & testing demonstrate that engineering changes achieve product performance, manufacturability, safety, customer and regulatory requirements.
  • Develop timelines and cost estimates for project tasks and appraise management of performance against plan to maintain compliance to project schedule
  • Generate and review design history file documentation in compliance with GMP, QSR, ISO and company requirements throughout the project life cycle to ensure the design is fully documented
  • Assessment of NCRs and implementation of agreed corrective / preventative actions to maintain regulatory compliance

We are looking for someone who is/has:

  • Bachelor's degree or equivalent (e.g. NVQ level 5) in an appropriate Engineering discipline or STEM equivalent;

or
  • A Higher National Diploma/Certificate (HND/HNC) achieved through an apprenticeship programme in an appropriate Engineering discipline, with a minimum of 2 years' experience in a regulated industrial environment, preferably medical background but not essential.
  • Passionate about getting things done and making things better
  • Ideally medical device design or manufacturing experience
  • Good working knowledge of MS Office applications (Word, Excel, Outlook, etc.)
  • Knowledge of mechanical design relating particularly to mechanisms
  • Knowledge of and ability to critique 2D engineering drawings and 3D modelling
  • Strong problem solving skills
  • Excellent verbal and written communication skills
  • Able to work as part of a team and meet project task deadlines
  • Experience of using process control tools i.e. control chart, pareto chart, cause and effect diagram
  • Knowledge of process deliverables particularly pFMEA, control plans, manufacturing plans and assembly aids (manufacturing work instructions)
  • Experience of process and equipment validation activities
  • Experience with using Minitab statistical software

We offer:

  • Hybrid Working
  • Bonus Scheme
  • Generous Pension Scheme
  • Free Life Assurance
  • Private Medical Insurance
  • 25 days Annual Leave (plus bank holidays)
  • Employee Assistance Programme

About ATL Technology

ATL Technology is a fast-growing provider of outsourced design, development and manufacturing services to the medical device market, and its UK site is based in St Mellons, Cardiff.

We believe that there is a better way to bring medical devices to market and 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.

Aside from our site in the UK, we also have operations in China, Costa Rica, Taiwan and the 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 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.

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