Design Engineer for Medical Devices

We are seeking an experienced Design Quality Lead to support Digital Health Technology (DHT) and Software as a Medical Device (SaMD) initiatives within a highly regulated medical device environment. This role will provide quality and regulatory oversight for AI-enabled medical technologies throughout the product development lifecycle. The ideal candidate will collaborate cross-functionally with Quality, Regulatory Affairs, Product Development, and external business partners to ensure compliance with global medical device regulations and quality standards. Key Responsibilities Develop and maintain QMS procedures, SOPs, and guidance documentation supporting Digital Health and SaMD initiatives Ensure compliance with ISO 13485, FDA 21 CFR Part 820, IVDR, MDR, and IEC 62304 requirements Provide quality oversight for Design Control activities including risk management, CAPA, change control, and design reviews Support supplier qualification and quality oversight activities for external business partners Review and support technical documentation, DHF deliverables, and regulatory submission packages Participate in product development activities to ensure quality and compliance requirements are integrated throughout the lifecycle Support audit readiness, inspection preparation, and regulatory compliance initiatives Collaborate with cross-functional stakeholders to identify and mitigate quality and compliance risks Assist in review and response activities for regulatory agency questions and submissions Required Qualifications Bachelor’s degree in Engineering, Science, or related discipline 7+ years of Quality or Regulatory experience within medical devices or SaMD environments Strong understanding of Design Controls and medical device development lifecycle Experience with FDA 21 CFR Part 820, ISO 13485, IEC 62304, MDR/IVDR, and risk management principles Experience supporting CAPA, change control, DHF documentation, and regulatory compliance activities Strong communication, collaboration, and problem-solving skills Ability to work effectively within a matrixed and cross-functional environment Preferred Qualifications Experience supporting AI-enabled Digital Health Technologies or Software as a Medical Device products Experience supporting 510(k), PMA, or De Novo regulatory submissions Prior experience working with global regulatory and quality teams #J-18808-Ljbffr Pharmaceutical Company