Senior R&D Engineer: Drug‑Device Innovation Leader

Cordis; Irvine (CA); On-site; USD 98,000 - 131,000; Full time

Job summary

Cordis, in collaboration with Selution, seeks a Senior R&D Engineer to lead development of drug-device combination platforms for cardiovascular therapies. You will oversee design, optimization, and validation, ensuring alignment with FDA 21 CFR Part 820 and ISO 13485, while mentoring junior engineers.

Responsibilities include leading design, development and testing of drug-device systems such as drug-coated balloon catheters; driving prototyping and process improvements; coordinating design

Qualifications

• Bachelor’s degree in Mechanical, Biomedical, or Chemical Engineering.
• 5+ years of R&D/product development experience in the medical device industry.
• In-depth knowledge of design controls, risk management, and validation processes.
• Strong CAD skills (SolidWorks preferred).
• Proven leadership and project management experience.

Responsibilities

• Lead design, development, and testing of combination drug-device systems including drug-coated balloon catheters.
• Drive concept generation, prototyping, and product improvement initiatives.
• Manage design control documentation and ensure compliance with FDA 21 CFR Part 820 and ISO 13485 requirements.
• Plan and execute verification and validation studies.
• Collaborate cross-functionally with Analytical Chemistry, Manufacturing, and Quality teams.
• Provide technical oversight during technology transfer and process scale-up.
• Support regulatory submissions with design and technical documentation.
• Mentor and guide junior engineers in technical and professional development.
• Identify and implement process improvements to enhance design efficiency.
• Participate in design reviews, FMEA, and risk assessments.

Skills

Leadership

Project management

Communication

Problem solving

Education

Bachelor’s degree in Mechanical, Biomedical, or Chemical Engineering

Tools

SolidWorks

Job description

Cordis, in collaboration with Selution, seeks a Senior R&D Engineer to lead development of drug-device combination platforms for cardiovascular therapies. You will oversee design, optimization, and validation, ensuring alignment with FDA 21 CFR Part 820 and ISO 13485, while mentoring junior engineers.

Responsibilities include leading design, development and testing of drug-device systems such as drug-coated balloon catheters; driving prototyping and process improvements; coordinating design