1 to 3 of 3 Permanent Product Requirements Jobs in Cambridgeshire

of firmware for embedded products and systems (user interfaces, sensors, wireless comms etc) Demonstrate examples of planning and estimating software development work and capturing product requirements Ability to apply scientific/engineering principles when problem solving Test-driven development, agile, continuous integration and unit testing experience and how more »

Engineer, contributing to the development and refinement of cutting-edge diagnostic systems. Your role will be pivotal in perfecting the electronics design of the product as they move towards launch. You'll work closely with the team and collaborate with an external electronics team to ensure smooth knowledge transfer … Engineer to join the team. You will be responsible for defining, designing, and executing verification and validation activities, ensuring our diagnostic systems meet regulatory requirements and are ready for product launch. Key Responsibilities Support verification and validation processes to prepare the system for clinical studies and FDA approval. … System (eQMS). Develop Work Instructions and Standard Operating Procedures (SOPs). Collaborate with Engineering, Manufacturing, and Biology teams to achieve regulatory submission and product launch. Ensure compliance with ISO 13485/FDA regulatory requirements. Qualifications To be successful in this role, you should have: Practical experience in verification more »

and validation protocols. Your contributions will be crucial in ensuring the successful execution of validation and verification activities required ahead of regulatory approval and product launch. Responsibilities include: Supporting with verification & validation to prepare the LEX System for clinical study and FDA approval. Implement verification and validation test plans … and protocols for the system/product, documenting all activities within the Quality Management System (eQMS). Contribute to the development of Work Instructions and Standard Operating Procedures (SOPs). Collaborate with the Engineering, Manufacturing and Biology teams working towards regulatory submission and product launch. Adhere to the … requirements of working in an ISO 13485/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 more »