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Design Assurance Engineer
4 months ago
Our client is a leading innovator in the healthcare industry, specializing in the development and production of cutting-edge medical devices. Their mission is to improve patient outcomes and quality of life through advanced technology and rigorous quality standards.
They are seeking a highly skilled and detail-oriented Design Assurance Engineer to join their team. In this role, you will be responsible for ensuring the quality and compliance of our medical device designs throughout the product development lifecycle. You will collaborate closely with cross-functional teams to implement design controls, conduct risk assessments, and drive continuous improvement initiatives.
Key Responsibilities:
Develop and implement design control processes and procedures in compliance with regulatory requirements (e.g., FDA, ISO). Conduct risk assessments and mitigation strategies for new and existing product designs. Review and approve design documentation, including design input/output, verification/validation protocols, and design change assessments. Lead design reviews and provide guidance on design best practices and regulatory requirements. Collaborate with R&D, Quality Assurance, and Regulatory Affairs teams to ensure alignment on design quality and compliance objectives. Participate in audits and inspections, providing documentation and support as needed. Drive continuous improvement initiatives related to design assurance processes and practices. Stay current with industry trends, standards, and regulations related to medical device design and quality assurance.Qualifications:
Bachelor's degree in Engineering or related field (Master's degree preferred). 2+ years of experience in design assurance/engineering roles within the medical device industry. Strong knowledge of FDA regulations (e.g., 21 CFR Part 820) and ISO standards (e.g., ISO 13485). Experience with risk management methodologies (e.g., FMEA, Hazard Analysis). Proficiency in design control tools/software (e.g., PLM systems, design verification/validation tools). Excellent communication, collaboration, and problem-solving skills. Certification in Quality Engineering (e.g., ASQ CQE) is a plus.Benefits:
Competitive salary and benefits package. Opportunities for professional development and career growth. A collaborative and supportive work environment focused on innovation and excellence.If you are passionate about ensuring the quality and safety of medical devices and want to make a meaningful impact in healthcare, we encourage you to apply for this exciting opportunity.
