Validation & Verification Engineer

Job Location	Leam Lane
Education	Not Mentioned
Salary	Competitive salary
Industry	Not Mentioned
Functional Area	Not Mentioned
Job Type	Permanent, full-time

Job Description

Our client, an award winning Manufacturing Company, are looking to appoint a Validation & Verification Engineer.Job Purpose of the Validation & Verification Engineer:

To assist in all aspects of the Design Departments scope of responsibilities.

To be able to examine ISO/BS/EN Standards relating to New Product Development and create a validation & verification protocol for each said product from those standards deemed relevant.

To learn existing technologies and test methods to allow seamless interaction with the Quality Department whilst taking these developments from early concept testing to small production batches.

To assist in the completion of documentation within the design process and facilitate stage sign offs within our Q-Pulse system.

Main Duties of the Validation & Verification Engineer:

Examine relevant ISO/BS/EN standards using our onsite Compliance Navigator for specific projects creating a validation and verification protocol for each said project.

Work within the requirements of BS EN ISO 13485:2016 and 14971:2012.

Produce a report outlining the relevant information to the Designer in control of the project and the associated QA technician. When required assist in the implementation of new products in accordance with the relevant SOP for Product Development.

Maintain and contribute to the product development documentation as set out in SOP 2200 and EEC regulations required to comply with Good Manufacturing Practice (GMP).

When required support the improvement of existing products after introduction and during their sales life.

Assist with drawing changes as a result of changes to the specification.

To learn existing technologies/processes and act as technical back-up to all teams when required.

To maintain comprehensive and accurate records of all work in the formats required.

Assist QA with testing requirements within the design and development program.

Perform early concept testing required for Stage 2 product development and present this to the relevant QA Technician for embedding into the New Product Development/QA filing system in readiness for Stage 3 testing.

Assist with Tool Trial Procedure. Keep up to date with developments in processes, materials and manufacturing methods.

To keep up to date on latest developments, training and pass on this knowledge to all teams.

In conjunction with the QA department, assist with testing and reporting on new or alternative components and material introduction. Accept any reasonable request by the Marketing Director, Design Manager or company Director, after if necessary, negotiation.

Attend external visits as required (clinics, operating theatres etc) to achieve the desired product formats.

Assist in the design and development of relevant machinery, tooling, equipment and processes to ensure we maintain high quality, safe, effective and minimum cost products, new or existing.

Contract Type: Permanent (Subject to completion of 6 month probation period).Hours of Work: 39 hours. 8am-5pm Mon-Thurs (30 mins for lunch), 8am-1pm Fri.Flexible Working is offered for this position. Employee is able to build a Flexible allowance 2 days credit/1 day deficit. No overtime payment will be made. Required skills

medical

design

development

diagnostic

manufacturing

verification

validation

medical device

certification

device

single use

Keyskills :
medical design development diagnostic manufacturing verification validation medical device certification device single use

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