manufacturing. Maintain accurate documentation and lab records. Introduce innovative technologies and make informed recommendations. Manage project scopes, resources, and budgets effectively. Ensure compliance with ISO13485 standards. Requirements: Essential: Bachelor's degree or higher in a biological-related discipline, with significant post-qualification experience. Minimum of 3 years … experience in people management. Proven ability to lead, motivate, and mentor a team of scientists. Thorough understanding of product design control and ISO13485 regulations. Extensive experience in molecular biology techniques such as FISH, PCR, DNA manipulation, and fluorescent labelling. Previous work in a regulated, diagnostic environment. Strong … software tools such as BLAST/BLAT and sequence searching methods. Comprehensive knowledge of genomic principles and databases. Additional management experience preferred. Experience in ISO 9001 and ISO13485 compliant environments, including participation in audits. If you are ready to make a significant impact in a research more »
Royston, Hertfordshire, South East, United Kingdom
Vector Recruitment Ltd
of diagnostic technology! Due to the imminent global release of this product, you will need to adhere to the requirements of medical device regulations – ISO13485/FDA environments. As the Senior Verification & Validation Engineer, your responsibilities will include: Lead the planning of verification activities for the system … Instrument and test consumable. Ensure tests are designed in alignment with product requirements will full traceability. Adhere to the requirements of working in an ISO13485/FDA regulated environment. Implement verification and validation test plans and protocols for the system/product, documenting all activities within the … degree or equivalent hands-on experience. Recent and relevant practical experience in verification of In Vitro Diagnostic (IVD) devices or medical devices in an ISO13485/21CFR regulated environment. Experience in writing, editing, or addressing product requirements. Proficiency in both Mechanical and Electrical Engineering disciplines. Track record of submitting regulated more »
Bury St. Edmunds, Suffolk, East Anglia, United Kingdom
Little Black Dog Recruitment Limited
to the technical file for regulatory submission of the medical products. Managing project timelines and project team workloads. Generating project documentation in line with ISO13485 and other medical device regulatory requirements. Working closely with the customer to gather relevant concept information. Work closely with the design team …/or training will be provided to assist carrying out these responsibilities. As a medical device manufacturer, our design and development processes comply with ISO13485 requirements. This position will require organisational and communication skills (verbal and written), problem solving skills, cross-functional teamwork and the ability to more »
experience:Minimum of 5 years’ experience in developing software and troubleshooting hardware issues.Previous involvement in regulated In Vitro Diagnostic (IVD) development, including operating under ISO13485 and IEC62304.Significant experience in formal software verificationProficiency in C/C++ programming languages.Experience with Real-Time Operating Systems (RTOS) and bare-metal development.A demonstrated track more »
Minimum of 5 years’ experience in developing software and troubleshooting hardware issues. Previous involvement in regulated In Vitro Diagnostic (IVD) development, including operating under ISO13485 and IEC62304. Significant experience in formal software verification Proficiency in C/C++ programming languages. Experience with Real-Time Operating Systems (RTOS) and bare-metal more »
would be a strong benefit to have knowledge of NGS and molecular testing methods An appreciation of the regulatory requirements for a clinical laboratory (ISO 15189) and/or IVD, ISO13485 Good written and verbal communication skills, and able to work effectively in a busy and more »
with design control standards. Background in the medical device sector to understand regulatory requirements and quality management systems (QMS) essential for successful product development. (ISO13485) Knowledge in mechanical engineering with a focus on testing equipment and innovation in product development. Requirements: Bachelor's degree in Electronics or Mechanical Engineering. Up more »
accordance with design control standards.Background in the medical device sector to understand regulatory requirements and quality management systems (QMS) essential for successful product development. (ISO13485)Knowledge in mechanical engineering with a focus on testing equipment and innovation in product development.Requirements:Bachelor's degree in Electronics or Mechanical Engineering.Up to more »
concepts to diverse audiences. Strong knowledge of regulatory requirements and quality standards applicable to medical device development and manufacturing, such as FDA regulations and ISO 13485. Our Benefits: 26 days' holiday with the option to buy or sell an additional 5 Up to 10% employer pension contribution Share and more »
NeuroTech AIMDs.Understands the end-to-end process for Class III Medical Devices.Has worked with contract manufacturers or built an internal manufacturing capability.ISO understanding across ISO13485 requirements.How do I apply?To apply for this outstanding opportunity, please contact Nathan Sasso at Pivotal via email at nathan@pivotallondon.co.ukKey Skills more »
Royston, Hertfordshire, South East, United Kingdom
Vector Recruitment Ltd
and mechanical systems. Provide guidance to help develop and implement system improvements. Experience in writing, editing, or addressing product requirements. Previous experience working with ISO13485 beneficial. Sound like you or someone you know? If so, please do not hesitate to get in contact with Darren Holmes at Vector Recruitment Ltd more »
scalable, allowing personalised therapies to be affordable for more people. To commercialise their technologies, they are recruiting a Quality Manager to lead them through ISO 9001 and other regulations. This would include developing and building quality frameworks for all stages of project development and manufacture through the management of … all stakeholders. Requirements: Graduated with a bachelor's or master's in engineering or similar. Substantial demonstrable experience leading a company through ISO9001/13485 relating to medical device instrumentation development and manufacture. Further exposure to GMP manufacture for biological products would be desirable. Comprehensive experience with “quality management … offer is a healthy benefits package including private medical insurance (including immediate family dependents), enhanced company pension contributions and annual bonus. Keywords: ISO9001/13485, Quality Management, Auditing, Medical Devices, Regulations, Development, Manufacture, Cambs/Herts Border Another top job from ECM, the high-tech recruitment experts. Even if more »
refrigeration specifications are feasible to source by connecting to suppliers and manufacturing operations Provide specific documentation related to product design to meet regulatory compliance: ISO 9001, 13485 and organization requirements Assist on quality complains from the field by providing technical support to identify root cause, short- and long … and heat transfer Design Engineer will have experience working in formalized phase-gate product development process, using Design tools such as DFM, FMEA and ISO 9001 design controls Experience on SolidWorks (CAD) If you would like to find out more about this Design Engineer opportunity, click the "APPLY NOW more »
laboratory sector. The products are supported with a full range of laboratory services as well as comprehensive servicing and repair capability. The company is ISO13485 certified. We have an excellent opportunity in our Services Team for a Service engineer who is looking to build on their experience to date working … the ability to respond to emergencies. Experience of maintenance repairs, such as electrical, and plumbing. To have an understanding of Quality Standards such as ISO13485, ISO9001, ISO14001 or other applicable standards, working with a Quality Management System. Ability to work independently and manage time effectively. Maintain accurate records of maintenance more »
