15 of 15 ISO 13485 Jobs in the East of England

systems. Lead firmware architecture, requirements definition, and design from early concept through product release. Ensure firmware development is executed in accordance with a certified ISO 13485 Quality Management System, with practical application of IEC 62304 and ISO 14971. Act as the firmware compliance leader, guiding the team … experience developing firmware for regulated medical devices, with products that have reached clinical, commercial, or regulatory submission stages. Demonstrated experience working within an ISO 13485–certified Quality Management System. Strong practical knowledge of IEC 62304 medical device software lifecycle requirements and ISO 14971 risk management as applied ...

technical consultancy environment, with direct responsibility for client relationships and expectations. Strong understanding of the product development lifecycle in a regulated environment ideally ISO 13485, from early concept and requirements to verification, validation, regulatory submission and transition to manufacture. Confidence working with technical specialists from different disciplines, with … minimum 2.1 in a degree or equivalent professional experience in engineering, physical sciences, product design or another relevant technical discipline. Working knowledge of ISO 13485 or comparable product-development quality frameworks Familiarity with medical device risk management, ideally ISO 14971. Experience managing medical software development projects, ideally ...

improve engineering processes and elevate team capability. Product Development Experience delivering hardware‐based products through a structured development lifecycle in a quality‐driven environment (ISO 9001, ISO 13485, or similar). Comfortable with verification, design reviews, configuration control, interface management, and risk assessment. Experience collaborating with manufacturing ...

Compliance: Act in a role aligned to CAP/CLIA expectations; ensure testing and reporting practices meet regulatory and professional standards, including ISO 15189, GCP, IVDR and HTA requirements. - Result Authorisation and Interpretation: Review, interpret and approve laboratory results and reports, ensuring outputs are scientifically valid, clinically appropriate … laboratory environment. - Experience providing medical and technical oversight for testing within an accredited or regulated laboratory environment. - Strong working knowledge of CAP/CLIA, ISO 15189, GCP, IVDR, HTA and applicable standards governing laboratory quality systems, patient testing, and report issuance. - Experience reviewing, authorising, or providing medical oversight ...

invention of this cutting-edge medical device. Ideally, you will have worked within the Medical Devices sector previously and have good knowledge of ISO 13485, IEC 62304 and ISO 14971.The company has the unique ability to offer an excellent benefits package, unusual for a start-up, including ...

. Strong understanding of design control, product lifecycle management and regulatory change management. Hands-on experience with Risk Management in accordance with ISO 14971. Experience preparing or contributing to Clinical Evaluation Reports (CERs), Performance Evaluation Reports (PERs), Biological Evaluation Reports (BERs) and Post-Market Surveillance (PMS) documentation. Experience supporting … regulatory submissions and interactions with Notified Bodies and Competent Authorities. Working knowledge of ISO 13485 and associated regulatory standards. Excellent written and verbal communication skills, with the ability to communicate effectively across multidisciplinary teams. Highly organised, pragmatic and able to manage multiple regulatory projects within a fast-paced ...

will help invent and improve will save lives all around the world. It is essential that you have medical devices knowledge working within ISO 13485, EN 60601, IVDD or IEC 62304 standards. You will essentially have Embedded C programming along with C#, C++ and Java. As this company ...

Medical Devices and Life Sciences sectors, it would be ideal if you have worked on these types of technologies previously, specifically to ISO 13485 standards. However, we are open to people from other regulated sectors as your Embedded Software skills should be transferrable. You will be working alongside ...

experienced Electronics Engineers who are happy to work across several different projects. We ideally need someone who has past experience with Medical Devices within ISO 13485 or EN 60601 standards. While working on brand-new technologies, you will be problem-solving and thinking up exciting new ways ...

companies do not offer. Normally, we look for Electronics Engineers and Electronics Design Engineers who have been working within the Medical Devices sector to ISO 13485 and EN 60601 standards, however if you have been working within other highly regulated fields we may be able to look ...

Strong understanding of software development lifecycle and version control (e.g., Git). Desirable experiences for an Embedded Software Engineer: + Experience with IEC 62304, ISO 13485, or FDA 21 CFR Part 820 + 3+ years of experience in a regulated industry Apply today to join a highly innovative ...

teams to support the design, integration, and commercialisation of semiconductor-based and biocomputing technologies. Your role will span product architecture, documentation to ISO 13485 standards, and hands-on delivery of systems that combine hardware, software, and biology. You'll collaborate with internal stakeholders and external partners to align ...

Engineer to join their innovative medical devices team. The role involves developing safety-critical embedded firmware for insulin pump systems while ensuring compliance with ISO 13485 and other relevant standards. You will lead firmware architecture and work closely with cross-functional teams to establish best practices. The ideal ...

bioelectronic interfaces. Experience with wireless power, RF, inductive systems, or power‐conversion testing. Familiarity with test‐method validation, equipment qualification, design verification, or ISO 13485. Familiarity with IEC 60601, ISO 14708, or related medical‐device standards. Experience scaling engineering test systems toward production use. Benefits: Competitive salary ...

hardware. Data Optimisation: Analyse performance data to improve system robustness, sustainability, and efficiency. Compliance & Docs: Maintain technical specs and control logic descriptions compliant with ISO 9001 and ISO 13485. Requirements Degree in Control Systems, Mechanical, or Electrical Engineering. Proven contract experience in control systems design and system dynamics. ...