Cordis ยท 2 months ago
Research and Development Engineer I
Irvine, California
Full-time
Onsite
Entry Level
1+ years expCordis, in partnership with Selution, specializes in the development of advanced drug device combination products for critical medical needs. The R&D Engineer I will contribute to the design, prototyping, testing, and validation of innovative medical devices, collaborating with cross-functional teams to execute product development strategies.
Health CareHealth DiagnosticsMedical
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
Lead 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
Work closely with other functional teams to lead problem solving activities, product and process characterization
Develop and lead testing required for design development activities
Qualification
Required
Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related field
Minimum 1+ years of experience 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 non-technical audiences
Company
Cordis
Cordis Corporation, a Johnson & Johnson company, has pioneered less invasive treatments for vascular disease.
1001-5000 employees
H1B Sponsorship
Cordis has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (3)
2023 (3)
2022 (4)
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
Company data provided by crunchbase