Company:
Cordis
Location: Irvine
Closing Date: 18/10/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
Overview:
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 R&D Engineer to join our dynamic team of innovators in Irvine, California. As an 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.
Responsibilities:
• Collaborate with cross-functional teams, including product management, regulatory affairs, quality assurance, and manufacturing, to define and execute product development strategies.
• Design and develop novel combination medical devices, considering various factors such as usability, safety, manufacturability, and regulatory requirements.
• Conduct thorough research, analyze existing medical devices and technologies, and propose innovative solutions to address unmet clinical needs.
• Create detailed engineering specifications, drawings, and documentation to ensure accurate and comprehensive product design.
• Utilize CAD software to generate 3D models and 2D drawings of components and assemblies, performing design iterations and modifications as necessary.
• Conduct feasibility studies and proof-of-concept experiments to evaluate the performance, functionality, and safety of new device concepts.
• Participate in the selection and evaluation of materials, components, and suppliers to ensure the highest quality and reliability of the developed medical devices.
• Collaborate with external partners, key opinion leaders, and contract manufacturers to facilitate the successful transfer of projects from development to commercial production.
• Stay updated with the latest industry trends, emerging technologies, and regulatory requirements, incorporating relevant advancements into the design and development processes.
• Contribute to the preparation and submission of regulatory documents, including design dossiers, technical files, and patent applications, as necessary.
• Support the transfer of developed products to manufacturing, providing technical guidance and troubleshooting assistance during production ramp-up.
Qualifications:
• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field.
• Minimum of 1+ years of experience (depending on qualifications) in medical device research and development, with a focus on supporting complex projects and driving technical excellence.
• 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.
• 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 $80,500 - $108,000
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.
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 R&D Engineer to join our dynamic team of innovators in Irvine, California. As an 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.
Responsibilities:
• Collaborate with cross-functional teams, including product management, regulatory affairs, quality assurance, and manufacturing, to define and execute product development strategies.
• Design and develop novel combination medical devices, considering various factors such as usability, safety, manufacturability, and regulatory requirements.
• Conduct thorough research, analyze existing medical devices and technologies, and propose innovative solutions to address unmet clinical needs.
• Create detailed engineering specifications, drawings, and documentation to ensure accurate and comprehensive product design.
• Utilize CAD software to generate 3D models and 2D drawings of components and assemblies, performing design iterations and modifications as necessary.
• Conduct feasibility studies and proof-of-concept experiments to evaluate the performance, functionality, and safety of new device concepts.
• Participate in the selection and evaluation of materials, components, and suppliers to ensure the highest quality and reliability of the developed medical devices.
• Collaborate with external partners, key opinion leaders, and contract manufacturers to facilitate the successful transfer of projects from development to commercial production.
• Stay updated with the latest industry trends, emerging technologies, and regulatory requirements, incorporating relevant advancements into the design and development processes.
• Contribute to the preparation and submission of regulatory documents, including design dossiers, technical files, and patent applications, as necessary.
• Support the transfer of developed products to manufacturing, providing technical guidance and troubleshooting assistance during production ramp-up.
Qualifications:
• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field.
• Minimum of 1+ years of experience (depending on qualifications) in medical device research and development, with a focus on supporting complex projects and driving technical excellence.
• 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.
• 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 $80,500 - $108,000
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.
Share this job
Cordis