and resolve issues. Perform formal software verification. Qualifications To succeed in this role, you should have: Experience in regulated IVD development, including compliance with 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 »
development, detailed design, and design for manufacture for: medical and diagnostic devices, consumer personal electronics devices 3. Awareness of medical device processes and standards (ISO13485, 62304, 60601) 4. Experience in designing proof of concept (PoC) systems using Python/MATLAB and microcontrollers 5. Knowledge of machine learning and AI 6. 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 »
Instructions and Standard Operating Procedures (SOPs). Collaborate with Engineering, Manufacturing, and Biology teams to achieve regulatory submission and product launch. Ensure compliance with ISO13485/FDA regulatory requirements. Qualifications … To be successful in this role, you should have: Practical experience in verification of In Vitro Diagnostic (IVD) devices or medical devices within an ISO13485/21CFR regulated environment. Experience in writing test protocols aligned with Product Requirement Specifications. A degree in Science or Engineering or equivalent relevant experience. Experience … in medical device development and commercialization. Preferred Skills Hands-on experience in an ISO13485/FDA regulated environment. Strong background in developing and executing verification and validation protocols. Ability to collaborate effectively with cross-functional teams. Apply now as interviews are already being scheduled more »
Experience working with early-stage products. Experience developing approval ready devices and products. Experience with C++ & C also useful. Experience within Medical Devices Sector (ISO13485). If interested, please apply, or reach out for further information about the role more »
ll also develop prototype algorithmic functions based on data analysis and experimental findings. Additionally, you'll play a role in maintaining adherence to the ISO13485 quality management system and collaborate effectively with other engineers to support research and development initiatives and the overall project goal Better patient more »
activities and working to develop a capable and robust/stable process. Adhere to Quality Management System (QMS) requirements in line with Corin’s ISO13485 QMS & Good Manufacturing Practice (GMP) FDA21 CFR Part 820. Support brainstorming and problem-solving as required activities for inspection processes and assist in resolving engineering more »
Oxfordshire, England, United Kingdom Hybrid / WFH Options
Orion Electrotech
in circuit design, schematic capture, PCB layout, and simulation tools. Experience of version control systems (Altium, PDM etc) Familiarity with regulatory standards such as ISO13485 and IEC 60601 is a bonus but not a deal-breaker. Excellent problem-solving skills and attention to detail. Ability to thrive more »
Qualifications: Demonstrated experience in the design and development of products - Medical industry advantageous Design or Engineering Degree preferred Familiarity with regulatory standards and QMS - ISO13485 advantageous CAD proficient, preferably Solidworks Plastic manufacturing process knowledge If you want to be part of a team dedicated to making a meaningful impact in 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 »
maintenance and control of on-going (or future) compliance to all certifications and standards relevant to the company. These will include as a minimum: ISO13485 (including EU MDR and UK MDR). Fully support the pack assembly team within the production environment and the custom pack team with set up more »
. Collaborate with the Engineering, Manufacturing and Biology teams working towards regulatory submission and product launch. Adhere to the requirements of working in an ISO13485/FDA regulated environment. Experience … and skills required to be successful in this position: Practical experience in verification of In Vitro Diagnostic (IVD) devices or medical devices in an ISO13485/21CFR regulated environment. Previous experience in writing test protocols in line with Product Requirement Specifications. Degree in Science or Engineering or possess equivalent relevant more »
expanding the molecular products portfolio. The position holder will lead the technical development of new molecular reagents and associated methodologies, while working according to ISO13485 standards. The role may provide on a project need basis supervision for other team members, planning and coordinating various experimental work and … reagents, including PCR, isothermal amplification, and Next Generation Sequencing applications. Establish and disseminate technical knowledge and good laboratory practices in the group. Work to ISO13485 standards and understand their requirements. Independent planning, execution and troubleshooting of experiments. Write literature to support product launches. Keep accurate laboratory records. Assist with customers more »
report Skills and experience required: + Degree in relevant discipline + Proven experience in medical device development + Previously worked to relevant quality standards – ISO13485 + Experience in prototyping and testing + Strong 3D CAD skills + Experience in different manufacturing processes - injection moulding The salary will more »
s degree in relevant engineering discipline. Good communication and presentation skills 5 years experience (Min) in medical devices design and development with understanding of ISO13485 and IEC 60601 design control standards Multi-disciplinary engineering background (e.g., mechanics, electronics, software, data analysis and processing) with a generalist view more »
s degree in relevant engineering discipline. Good communication and presentation skills 5 years experience (Min) in medical devices design and development with understanding of ISO13485 and IEC 60601 design control standards Multi-disciplinary engineering background (e.g., mechanics, electronics, software, data analysis and processing) with a generalist view more »
s degree in relevant engineering discipline. Good communication and presentation skills 5 years experience (Min) in medical devices design and development with understanding of ISO13485 and IEC 60601 design control standards Multi-disciplinary engineering background (e.g., mechanics, electronics, software, data analysis and processing) with a generalist view more »
s degree in relevant engineering discipline. Good communication and presentation skills 5 years experience (Min) in medical devices design and development with understanding of ISO13485 and IEC 60601 design control standards Multi-disciplinary engineering background (e.g., mechanics, electronics, software, data analysis and processing) with a generalist view more »
s degree in relevant engineering discipline. Good communication and presentation skills 5 years experience (Min) in medical devices design and development with understanding of ISO13485 and IEC 60601 design control standards Multi-disciplinary engineering background (e.g., mechanics, electronics, software, data analysis and processing) with a generalist view more »
functional teams Experience in root cause investigation and analysis of failures to develop corrective and preventative actions Experience working with regulatory requirements, including AS9100, ISO13485, and IATF 16949, is a plus Experience working with suppliers and customers more »
all levels. Non clinical and clinical experience and being able to input into both RA and Clinical. Previous experience working within the requirements of ISO13485, the Medical Devices Directive (93/42/EEC), and/or the IVD Directive (98/79/EC). Lead more »
PHD and/or MBA within a relevant Scientific, Quality Management, or Engineering field Expertise and proven working experience with current ISO9001:2015 and ISO13485 standards Industry experience in a Quality role and in a Senior Leadership position (department head) Experience of running a medium-sized Life Science organisation Well more »
managing or supporting the management of scientific or engineering projects. Ability to work to the Company’s Quality Systems and Policies in line with ISO13485 standards. Advanced experience with Microsoft Word and Excel. Great communication skills. Be eligible to work full time in the UK without restriction. Excellent work ethic more »
Hands-on experience in electronics development within In Vitro Diagnostic (IVD) devices or a similar highly regulated industry. Strong understanding of relevant standards, including ISO13485, IEC 61010, and IEC 60601. Experience with: Motor control, including stepper and DC brushed motors. Temperature control using resistive heaters and Peltier devices. Optical systems more »
and supporting the operation in the maintenance of quality. Maintaining a thorough working knowledge of practices, procurement, licensing, and regulatory requirements (IVDR, UK MDR, ISO13485) in all areas associated within Pathology and in particular relating to design, development, manufacture and testing of NHSBT produced reagents. Having expert knowledge in in more »
