Cordis · 6 hours ago
Senior Design Assurance Engineer
Irvine, CA
Full-time
Onsite
Mid, Senior Level
$95K/yr - $128K/yr
5+ years expCordis, in partnership with Selution, specializes in developing advanced drug device combination products for treating coronary and peripheral artery disease. The Senior Design Assurance Engineer will provide technical and quality leadership, ensuring the safety and reliability of medical devices throughout the product development lifecycle, while collaborating with cross-functional teams to achieve regulatory compliance.
Health CareHealth DiagnosticsMedical
No H1B
Responsibilities
Lead Design Assurance Activities: Develop and execute design assurance strategies, plans, and processes to ensure compliance with applicable regulations, standards, and internal requirements
Risk Management: Facilitate risk management activities, including the identification, evaluation, and mitigation of risks throughout the life of the product. Lead the organization as the SME through the understanding of design and process FMEAs
Design Controls: Drive the implementation and maintenance of design control processes, including design input, design output, verification, validation, and traceability activities
Compliance and Regulatory Affairs: Ensure compliance with relevant regulatory requirements (such as FDA regulations, ISO standards, etc.) and collaborate with regulatory affairs teams to support submissions and audits
Cross-functional Collaboration: Collaborate closely with R&D, operations, quality, and other departments to ensure effective communication, alignment, and coordination of design assurance activities
Utilize your robust understanding of medical device design principles, human factors engineering, and clinical requirements to develop robust and user-centered products
Collaborate with external partners, key opinion leaders, and research organizations to identify and explore new opportunities for collaboration and technological advancements
Participate in the creation and execution of intellectual property strategies, including the drafting and filing of patent applications
Qualification
Required
Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field
5+ years of experience in medical device research and development/design control, with a focus on leading projects and driving technical excellence
Proven track record of successful development and commercialization of medical devices, preferably in interventional cardiology
Strong knowledge of medical device design principles, human factors engineering, and regulatory requirements (ISO 13485, ISO 14871, FDA guidelines, etc.)
Deep understanding of medical device regulations and standards, including FDA 510(k) and CE Marking requirements
Excellent problem-solving skills, with the ability to analyze complex technical challenges and provide innovative solutions
Demonstrated teamwork abilities, with experience leading cross-functional teams and driving project outcomes
Strong communication and presentation skills, with the ability to convey technical concepts to both technical and non-technical teammates
Passion for innovation, a proactive mindset, and the ability to thrive in a fast-paced and dynamic environment
Company
Cordis
Cordis Corporation, a Johnson & Johnson company, has pioneered less invasive treatments for vascular disease.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
unknown2021-03-12Acquired
Leadership Team
Scott Drake
Chief Executive Officer
Recent News
2025-11-11
TeamBest Global Companies
2025-11-07
News-Medical.Net
2025-11-01
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