Carreras

Your Mission:
As a Verification & Validation (V&V) Manager, you will manage the V&V team and 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:

• Assist in the design, procurement and commissioning of test equipment, jigs and fixtures
• Report any errors or bugs in the relevant queue or issue register to ensure prompt resolution
• Analyse test results and compile comprehensive reports, maintaining technical documentation
• Perform regular quality control testing of test equipment and organise test data for analysis
• Draft protocols and V&V test plans, using product knowledge to determine required
• outputs and assess compliance with predefined criteria
• Manage a small V&V team of an engineer and technician
• Conduct comprehensive V&V testing of product software, hardware (Electronics & Mechanical) and firmware
• Create and maintain V&V procedures, test software and templates
• Provide evidence of both internal and external regulatory compliance
• Develop and execute usability engineering processes (with IEC 62366-1/FDA guidelines) to ensure safety and efficacy of medical devices for end-users
• Ensure adherence to ISO 13485 standards (training will be provided)
• Complete the testing section of technical files prior to product launch
• Articulate comprehensive justifications for determining sample sizes
• Collaborate with Quality, Regulatory & R&D department
• Participate in Technical Team Innovation Days specifically focused on developing cutting-edge technology.

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 Your Mission: 

As Goods In Quality Operator you will be utilising a wide range of methods to receive in and quality check all products coming into the business. You will have an essential role in the quality control of our products ensuring they conform to the highest standards and meet the required safety and quality standards. The quality checks must be fully documented raising any defects or issues with supervisors and managers. 

Roles and Responsibilities: 

• First line testing and inspection of incoming products at goods in stage, to ensure that products are fully ready for dispatch when required and maintain available stock levels 
• Moving stock within the warehouses once goods in checks have been preformed 
• Troubleshooting issues and executing fault corrections 
• Liaising with operations/warehouse/technical departments to resolve issues 
• Maintaining concise test records 

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 Your Mission: 

As a Production and Quality Operator you will be utilising a wide range of methods to assemble and quality check our products. You will have an essential role in the production and quality control of our products ensuring they conform to the highest standards and meet the required safety and quality standards. The production and quality checks must be fully documented raising any defects or issues with supervisors and managers. 

Roles and Responsibilities: 

• First line testing and inspection of incoming products at goods in stage, to ensure that products are fully ready for despatch when required and maintain available stock levels 
• Assembly and full testing of final products 
• Troubleshooting issues and executing fault corrections 
• Liaising with operations/warehouse/technical departments to resolve issues 
• Maintaining concise test and production records 

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Como asociado de asuntos clínicos, coordinará actividades clínicas y regulatorias clave, incluidas la evaluación clínica, la vigilancia poscomercialización (PMS), el seguimiento clínico poscomercialización (PMCF) y la gestión de riesgos para dispositivos médicos. Trabajará en estrecha colaboración con el pequeño equipo de asuntos clínicos y médicos, contribuyendo al desarrollo exitoso, la introducción en el mercado y el mantenimiento de dispositivos médicos seguros y efectivos. También ayudará con las solicitudes de subvenciones para asegurar la financiación para la investigación y el desarrollo clínicos.

Evaluación clínica:

• Ayudar a coordinar y mantener los planes e informes de evaluación clínica con la consultoría designada, garantizando el cumplimiento de los procedimientos de la empresa y los estándares regulatorios.

Vigilancia postcomercialización (VMP):

• Ayudar a recopilar y analizar datos clínicos para respaldar la seguridad del dispositivo, actualizar archivos de gestión de riesgos e identificar posibles mejoras.

Seguimiento clínico posterior a la comercialización (PMCF):

• Contribuir a los estudios del PMCF, incluida la preparación de planes, la gestión de la recopilación de datos y la creación de informes para garantizar el cumplimiento de las regulaciones.

Gestión de riesgos:

• Colaborar con el equipo de gestión de riesgos, incluidas las revisiones periódicas de riesgos, para integrar los datos clínicos en el archivo de gestión de riesgos (RMF).
• Ayudar a evaluar los riesgos asociados con los estudios clínicos y los datos posteriores a la comercialización para respaldar la seguridad del dispositivo.

Biocompatibilidad:

• Ayudar a coordinar las pruebas y evaluaciones de biocompatibilidad con la consultoría designada para garantizar que los materiales del dispositivo sean seguros para el uso humano.
• Apoyar el desarrollo de documentación de biocompatibilidad, incluidos planes de pruebas, informes y presentaciones reglamentarias, garantizando el cumplimiento de la norma ISO 10993 y las normas relacionadas.

Desarrollo y actualizaciones de procedimientos operativos estándar

• Ayudar a actualizar y mantener los procedimientos operativos estándar (SOP) para las actividades clínicas, garantizando que se alineen con las regulaciones actuales y las mejores prácticas.

Apoyo para la solicitud de subvenciones

• Ayudar a identificar oportunidades de financiación y preparar solicitudes de subvenciones para investigación y desarrollo clínicos.

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As a Medical Writer will be part of the growing Clinical department at Bedfont. The Medical Writer specialises in medical devices and plays a crucial role in creating compelling and accurate content to support development, regulatory approval, and marketing.

Working closely with cross-functional teams, including Research & Development, Quality Assurance & Regulatory Affairs, and Marketing, the Medical Writer translates complex scientific and technical information into clear and engaging content tailored to various audiences, including healthcare professionals, regulatory agencies, and consumers.

• Collaborate with cross-functional teams to understand product specifications, clinical data, and regulatory requirements for medical devices
• Write and edit a variety of scientific and technical documents, including clinical study reports, regulatory submissions, product manuals, and marketing materials.
• Prepare clear, concise, and scientifically sound clinical documentation, including, but not limited to, Clinical Evaluation Plans (CEPs) and reports and Post Market Clinical Follow-Up (PMCF) plans and reports in accordance with medical device regulatory requirements and industry best practices.
• Perform regular quality control testing of test equipment and organise test data for analysis
• Help manage clinical evaluation processes to include developing detailed plans for conducting clinical evaluations, outlining objectives, methodologies, data sources and timelines.
• Conduct comprehensive Systematic Literature Reviews (SLRs) to gather relevant clinical data on similar medical devices, treatments, or technologies, and identify and review clinical studies, trials, and reports related to the medical device under evaluation.
• Interpret clinical evidence in the context of applicable regulations, standards, and guidelines (e.g., MEDDEV 2.7/1, MDR, FDA guidance).

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As a Warehouse Operator you will be responsible for assisting with the daily warehouse and global despatch activities in a busy and hands on Operations Department. You will be working in a small team and helping to complete monthly stock counts and annual stock takes.

• Processing, picking, packing, final invoicing and arranging delivery of customer orders
• Liaising with sales/production/couriers to troubleshoot and resolve issues ensuring cost and delivery efficiency
• Liaising with sales/production/Senior Stock Controller to ensure orders are dispatched on time
• Maintaining concise warehouse and despatch records
• Completing quality checks on incoming goods and ensuring correct storage conditions are met
• Ensuring accurate stock management through LV software
• Assisting with annual full stock takes
• Assisting with monthly stock counts
• Helping with the delivery and collection of exhibition equipment and goods
• Taking part in Health & Safety tasks in the warehouse and dispatch environments

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As the subject expert and sole Software Developer at Bedfont Scientific Ltd you will create innovative software solutions. You will predominantly be creating desktop applications to interface with Bedfont’s medical devices using USB and Bluetooth protocols. You will design intuitive and user-friendly graphical user interfaces (GUIs), enabling storage of patient results and communicating with hospital systems.

• Design and develop new desktop software applications specifically tailored to interface with Bedfont’s new and existing medical devices.
• Maintain existing desktop software applications.
• Collaborate with small cross-functional teams, including R&D, Regulatory Affairs and Marketing to define system requirements.
• Develop user-friendly interfaces for both patients and healthcare providers, enhancing accessibility and usability.
• Implement robust security measures to protect sensitive patient data in compliance with HIPAA, GDPR, Cybersecurity and other regulatory standards.
• Conduct testing and debugging of applications to ensure reliability and functionality across multiple platforms and devices prior to prerelease testing.
• Create and maintain documentation throughout the software development process to ensure adherence to industry and medical device standards (such as IEC 62304).
• Responsible for reporting the latest advancements in software languages, development tools and vulnerabilities.
• Participate in Technical Team Innovation Days specifically focused on developing cutting-edge technology.

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