Sr. 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 seeking a talented and motivated Sr. R&D Engineer to join our dynamic team of innovators in Irvine, California. As an Sr. R&D Engineer, you will play a pivotal role in the development and enhancement of our combination medical devices. Working closely with a multidisciplinary team, you will contribute to the design, prototyping, testing, and validation of innovative medical devices that have the potential to transform patient care.

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 and oversee the design and development of innovative medical devices, from concept to commercialization, ensuring adherence to project timelines, budget, and regulatory requirements.
• Work closely with cross-functional teams, including product management, regulatory affairs, quality assurance, and manufacturing, to define product requirements and develop robust project plans.
• Utilize your deep understanding of medical device design principles, clinical requirements, and regulatory standards to guide the development process and ensure compliance with applicable regulations (e.g., FDA, ISO).
• Employ advanced engineering techniques and methodologies to develop novel solutions, including computational modeling, simulation, and prototyping.
• Conduct feasibility studies and perform risk assessments to evaluate the technical viability and commercial potential of new device concepts, considering factors such as usability, safety, efficacy, and manufacturing feasibility.
• Lead and contribute to the creation of detailed engineering specifications, design verification and validation plans, and documentation to support the development process.
• Utilize CAD software (e.g., SolidWorks) to generate detailed 3D models, assemblies, and manufacturing drawings, providing guidance and support to junior engineers when necessary.
• Collaborate with external partners, key opinion leaders, and contract manufacturers to ensure effective transfer of projects from development to manufacturing, providing technical guidance and oversight during scale-up activities.
• Stay abreast of the latest advancements in medical device technologies, industry trends, and regulatory changes, integrating this knowledge into the development process and providing technical leadership within the organization.
• Support the preparation and submission of regulatory documents, including technical files, design dossiers, and patent applications, ensuring compliance with relevant regulations and guidelines.
• Mentor and provide technical guidance to junior engineers, fostering their professional growth and development within the organization.

• Minimum Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field.
• Combination device experience required.
• Minimum of 5+ 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 $100,000 - $134,000
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.