SciPro are supporting a Medical Device company in their search for a Senior Design Assurance Engineer to join them on an initial 6-month contract, with the chance of extension. They need someone to support design verification activities, as well as regulatory compliance for FDA submission.The RoleYou will be responsible for ensuring that product designs meet user needs, intended uses, and applicable regulatory requirements through robust verification and validation activities. This role involves close collaboration with cross-functional teams including R&D, Quality, Clinical, and Regulatory Affairs to ensure compliance with FDA and international standards.Key ResponsibilitiesContribute to the creation and execution of design verification testing, including sterilization procedures.Participate in validating testing methods to confirm accuracy and reliability of DV testing results.Manage and coordinate biocompatibility assessments, ensuring adherence to ISO 10993 standards.Assist in evaluating usability studies involving pre-clinical trials, clinicians, and patients.Review, approve, and support R&D documentation intended for FDA submission.Aid in the preparation and validation of eSTAR submission documents, ensuring accuracy and completeness.Maintain compliance with relevant regulatory and quality standards, including ISO 13485, ISO 14971, and IEC 62366.Partner with Quality, R&D, Clinical, and Regulatory teams to align verification and validation activities with project timelines.Provide guidance and technical expertise during product build and DV&V execution phases.Foster effective communication with internal teams and external stakeholders to support the development of customer-focused product solutions.RequirementsExperience in medical device verification, validation, or design assurance.Knowledge of FDA Design Control requirements and ISO standards (ISO 13485, ISO 14971, ISO 10993, IEC Experience preparing or reviewing regulatory submissions (e.g., FDA 510(k), eSTAR).Strong organizational, documentation, and communication skills.Ability to manage multiple priorities and work collaboratively across teams.Please apply within or email me at with a copy of your CV if you feel that you meet the above criteria.