Description
Mechanical Technician/EngineerLocation:
A lot of the company are working from home at the moment. The client is based in Southend-on-Sea. The documentation could be done working from home but this role would require the successful person to go into the office to do the test work which would maybe be once a week or fortnight
Start date:
They would expect this person to start ASAP as they need someone on board very quickly. Ideally starting no later than the 17th of August but hoping for someone before that
Interview process:
Is likely to be via Zoom but they may want you to meet up with one of the team,which would be a face to face in the office - Southend-on-Sea
Duration: Required contract period to be 3 6 months starting ASAP.
The role:
We are seeking an enthusiastic and motivated individual to support my clients development/engineering team, with a hands-on approach including.
- Verification and validation testing.
- Preparation of supporting documentation, including specifications, design requirement protocols and test records.
- Preparation of instructions for use.
- To liaise with outside contractors regarding Labelling and drawings to meet the MDR requirements.
- At the present time there is no resource to carry out these test validations and this work has become more challenging whilst my client are working remotely. Without the resource this would result in a delay in satisfying the projected timeline requirements for MDR. The internal timeline is to deliver by end of Dec 2020 and they feel they will miss this by few months without additional support. Consequence to the business is we will not be ready to launch products to market under MDR.
Primarily this role will be working on the documentation which is verification and test reports. They have a number of templates so you will be given a explanation of what's required.
The other part of this role is to do some test work to verify the validations in house. It is not extensive testing but they just want to ensure the material is fit for purpose and then they need someone to record the test data.
Skills and experience:
- It is not essential to be at degree level for this role, they will consider people at a technical level but they need someone who's going to pick this up and run with it enthusiastically and get the job done
- The successful person won't be left to their own devices, there are people who can assist you
- Practical and evidenced knowledge of mechanical engineering and manufacturing technologies
- Ideally experienced in medical device and development
- Familiarity in working under an ISO 13485 quality and ISO 14971 risk management system
- Experience of SolidWorks, Microsoft Office