Principle R&D Engineer, Selution (Irvine, CA) - Cordis

MedAlliance, 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. MedAlliance is headquartered in Switzerland, with offices in Germany, Singapore, UK and the United States (Irvine, CA).

We are currently in search of an exceptionally experienced and accomplished Principal R&D Engineer to become a valued member of our exceptional team in Irvine, California. As a Principal Engineer specializing in Combination Devices within our R&D division, you will assume a pivotal role in propelling innovation and offering your technical expertise to advance our state-of-the-art medical devices to approval. You will work in close collaboration with cross-functional teams, serve as a mentor to junior engineers, and actively contribute to the strategic expansion of our product portfolio.

At the forefront of our medical innovations is our flagship product, SELUTION, representing a groundbreaking leap forward in the realm of medical devices. SELUTION integrates pharmaceuticals with a traditional balloon catheter, significantly enhancing the efficacy of treatments for patients afflicted by coronary and peripheral artery disease. With the approval of four Investigational Device Exemptions (IDEs) and an ongoing enrollment of patients, Cordis remains at the forefront of delivering transformative and life-changing medical solutions.

• Lead the research, design, and development of next-generation medical devices, leveraging your expertise to drive innovation and achieve technical excellence.
• Provide technical leadership in developing and executing R&D strategies, aligning them with business goals, market trends, and regulatory requirements.
• Collaborate with cross-functional teams, including product management, regulatory affairs, clinical affairs, quality assurance, and manufacturing, to define project goals, timelines, and deliverables.
• Utilize your deep understanding of combination devices, medical device design principles, human factors engineering, and clinical requirements to develop robust and user-centered products.
• Apply advanced engineering tools and methodologies to optimize device performance, including computational modeling, simulation, and advanced analysis techniques.
• Lead the creation of detailed engineering specifications, design verification and validation plans, and technical documentation, ensuring compliance with regulatory standards and guidelines.
• Utilize CAD software (e.g., SolidWorks) to generate detailed 3D models, assemblies, and manufacturing drawings, guiding junior engineers and providing technical support.
• Drive innovation through the evaluation and implementation of emerging technologies, materials, and manufacturing processes, enhancing product performance and manufacturability.
• Collaborate with external partners, key opinion leaders, and research organizations to identify and explore new opportunities for collaboration and technological advancements.
• Stay at the forefront of medical device advancements, regulatory changes, and industry trends, integrating this knowledge into the development process and providing strategic guidance.
• Mentor and provide technical guidance to junior engineers, fostering their professional growth and development within the organization.
• Participate in the creation and execution of intellectual property strategies, including the drafting and filing of patent applications.

• Minimum Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field.
• Combination device experience required.
• Minimum of 8+ years of experience (depending on qualifications) in medical device research and development, with a focus on leading complex projects and driving technical excellence.
• Proven track record of successful development and commercialization of medical devices, preferably in interventional cardiology, orthopedics, or related fields.
• Strong knowledge of medical device design principles, human factors engineering, and regulatory requirements (ISO 13485, FDA guidelines, etc.).
• Proficiency in CAD software (e.g., SolidWorks) for 3D modeling, design analysis, and manufacturing drawings.
• Experience with advanced engineering tools and methodologies such as computational modeling, simulation, and finite element analysis.
• Deep understanding of medical device regulations and standards, including FDA PMA/510(k) and CE Marking requirements.
• Excellent problem-solving skills, with the ability to analyze complex technical challenges and provide innovative solutions.
• Demonstrated leadership 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
• 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 $140,000 - $175,000
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.

Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All our teammate’s points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming.