Explore specialized Risk Manager & Design Control Engineer jobs, a critical hybrid role at the intersection of engineering, quality assurance, and regulatory compliance, primarily within highly regulated industries like medical devices, aerospace, and automotive. Professionals in this dual-capacity discipline serve as the guardians of product safety and efficacy, ensuring that design innovation is seamlessly integrated with rigorous risk mitigation strategies throughout a product's entire lifecycle. The core of this profession involves mastering and implementing two interconnected frameworks: Risk Management (per standards like ISO 14971) and Design Controls (per regulations like FDA 21 CFR Part 820 or ISO 13485). A Risk Manager & Design Control Engineer is typically responsible for planning and leading risk management activities, including hazard analysis, risk assessment, evaluation, and control. They develop and maintain crucial documentation such as Risk Management Files and Failure Mode and Effects Analyses (FMEAs). Concurrently, they support or lead Design Controls processes, ensuring that product development follows a structured, traceable path from user needs and design inputs through verification, validation, and design transfer to manufacturing. They are tasked with creating, updating, and reviewing engineering documents, design history files (DHF), and standard operating procedures (SOPs) to maintain continuous compliance. Common daily responsibilities include facilitating risk review meetings, collaborating cross-functionally with R&D, Quality, Regulatory Affairs, and Operations teams, and ensuring that risk management is an active, living process from initial concept through post-market surveillance. They play a key role in auditing and ensuring that the product design and its associated processes meet all applicable regulatory requirements and updated standards. Furthermore, they are often the point persons for interpreting new regulations and seamlessly integrating them into existing quality management systems. Typical skills and requirements for these jobs include a bachelor’s degree or higher in engineering or a related technical field, coupled with several years of experience in a regulated industry. In-depth knowledge of relevant standards (ISO 14971, ISO 13485) and regulations (EU MDR, FDA QSR) is mandatory. Successful candidates possess strong analytical and problem-solving abilities, exceptional technical writing and documentation skills for creating clear, compliant records, and a meticulous attention to detail. A collaborative mindset, excellent communication skills, and project management capabilities are essential, as the role involves constant interface with diverse teams and external partners. Fluency in the language of business and regulation is a must. For those seeking a career where technical expertise directly impacts product safety and public trust, Risk Manager & Design Control Engineer jobs offer a challenging and profoundly impactful professional path.
