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    Test Engineer - Maidstone, Kent, United Kingdom - Bedfont Scientific Ltd

    Bedfont Scientific Ltd
    Bedfont Scientific Ltd Maidstone, Kent, United Kingdom

    1 week ago

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    Description

    Senior Test Engineer Salary Range:
    £40,000 - £50,000

    The Story:
    Established in 1976, Bedfont is an award-winning medical technology company based in Harrietsham, Kent. Its breath analysis medical devices are exported globally thanks to its network of carefully selected distributors.
    Healthcare is evolving and the market for breath analysis monitors is expanding.

    Bedfont are looking for hard-working, like-minded, and passionate individuals to join the Bedfont Family to help achieve its goal of innovating healthcare worldwide.

    25 days paid holiday plus bank holidays
    ~ Social events
    ~ Private healthcare
    ~ Optical allowance
    ~ Bike-to-work scheme
    ~ Pension scheme
    ~ Bonus scheme
    ~ Hybrid Working
    ~ Employee Assistance Program
    ~ Free on-site parking
    ~ Training & Development Opportunities
    ~ As a Senior Test Engineer, you will not only manage the Verification & Validation (V&V) team but also hold a pivotal position in safeguarding the quality, safety, and effectiveness of our medical devices through rigorous V&V procedures. You will work closely with cross-functional teams to design, develop, and execute comprehensive test plans, while adhering to regulatory standards and industry best practices.
    Manage the V&V team, ensuring efficient operations and optimal performance.

    Develop and execute usability engineering processes in accordance with IEC and relevant FDA guidelines to ensure the safety and efficacy of medical devices for end-users.

    Responsible for creating and maintaining V&V procedures, software, and templates.
    Conduct comprehensive V&V testing of product software, hardware and firmware as necessary.
    Perform regular quality control testing of test equipment and organise test data for analysis.
    Provide evidence of both internal and external regulatory compliance.
    Troubleshoot abnormal testing results and address issues identified by other team members.
    Ensure adherence to ISO 13485 standards, with training provided if necessary.

    Complete the testing section of technical files prior to product launch, collaborating with the technical team and the Regulatory Affairs Department.

    Assist in the design, procurement, and commissioning of test equipment, jigs and fixtures as required.
    Bachelors or Masters degree (or equivalent experience) in Biomedical Engineering, Human Factors Engineering or a related field
    Minimum of 5 years of experience in medical device V&V, with a focus on complex electromechanical systems or equivalent
    Proficiency in test plan development, test protocol creation, and test execution, utilising tools and techniques such as statistical analysis, design of experiments (DOE), and risk assessment methodologies
    Strong analytical and problem-solving skills, with the ability to interpret complex data and draw meaningful conclusions
    Excellent written communication skills, including proficiency in report writing
    Enthusiasm for engineering and an interest in staying updated with industry developments
    IT literacy, with competence in utilising software planning tools for efficient project management
    In these circumstances training will be given where it is considered.

    Bedfont Scientific Ltd.

    does not and will not discriminate in the recruitment or managing of staff on the basis of race, colour, religion, gender, age, disability, marital status, sexual orientation and more.

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