Senior Test Engineer Salary Range: £40,000 - £50,000 Location: Harrietsham, Kent 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. The Challenge: 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. The Benefits: 25 days paid holiday plus bank holidays Social events Private healthcare Well-being warriors Optical allowance Bike-to-work scheme Pension scheme Bonus scheme Hybrid Working Employee Assistance Program Rewards App Employee awards Free on-site parking Training & Development Opportunities Uniform Your Mission: 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. Roles and Responsibilities: Manage the V&V team, ensuring efficient operations and optimal performance. Develop and execute usability engineering processes in accordance with IEC 62366-1 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. Proficient in articulating comprehensive justifications for determining sample sizes. Draft protocols and V&V test plans, leveraging in-depth product knowledge to determine required outputs and assess compliance with predefined criteria. Perform regular quality control testing of test equipment and organise test data for analysis. Analyse test results and compile comprehensive reports, maintaining technical documentation. Report any errors or bugs in the relevant queue or issue register, ensuring prompt resolution. 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. Qualifications and Education Requirements: 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 Valuable Expertise: Demonstrated proficiency in leadership, with proven ability to effectively lead and coordinate cross-functional work Strong attention to detail to meticulously scrutinise every test result and measurement, promptly identifying discrepancies Analytical thinking with the ability to not only detect issues but also propose potential causes and solutions Experience collaborating with individuals across the manufacturing process, fostering productive working relationships 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 Experience in creating plans, protocols, and reports, demonstrating organisational and documentation skills Highly communicative, articulate, and self-motivated IT literacy, with competence in utilising software planning tools for efficient project management Strong decision-making skills, coupled with good judgement, to navigate complex situations effectively In addition, employees may be required to undertake other duties as may reasonably be required of them. 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. We are an equal opportunity employer and Bedfont regards every employee as a member of the Bedfont family and is committed to providing a fair, safe, diverse and welcoming atmosphere. Our application process has been designed so that everyone is able to demonstrate their skills and how they meet the criteria required for the job advertised. If you are interested in applying for this role, please visit https://www.bedfont.com/careersto apply.