Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs.

We are seeking an experienced Senior Design Assurance Engineer to join our talented team in Irvine, CA. As the Senior Design Assurance Engineer, reporting to a Design Assurance manager, you will play a critical role in providing technical and quality leadership ensuring the safety, reliability, and design control of our medical devices throughout the product development lifecycle and the ongoing expansion of our Irvine facility. You will lead design assurance activities including project and site initiatives, collaborate with cross-functional teams and drive the implementation of best practices to achieve regulatory compliance and product excellence.

Key Responsibilities

• Lead Design Assurance Activities: 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.

Required Qualifications:

• 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.

Pay / Compensation
The expected pre-tax pay rate for this position is $94,600 - $127,600 per year. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.