Senior R&D Engineer

Cordis, LLC; Irvine (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Selution, in partnership with Cordis, seeks a Senior R&D Engineer to lead drug-device combination product development, including design, optimization, and validation of devices.

You will mentor junior engineers, manage design controls and regulatory documentation (FDA 21 CFR Part 820; ISO 13485), and collaborate across QA, Manufacturing, and Analytical teams.

Qualifications

• Bachelor’s degree in Mechanical, Biomedical, or Chemical Engineering.
• 5+ years of R&D or 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 balloons.
• Drive concept generation, prototyping, and product improvements.
• Manage design controls documentation and ensure FDA 21 CFR Part 820 and ISO 13485 compliance.
• Plan and execute verification and validation studies.
• Collaborate with Analytical Chemistry, Manufacturing, and Quality teams.
• Provide technical oversight during technology transfer and scale-up.
• 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

Design controls

Risk management

Validation

CAD skills

Education

Bachelors in Engineering

MS/PhD in engineering

Tools

SolidWorks

Job description

Overview

Selution, 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.

Responsibilities

The Senior R&D Engineer is responsible for leading product and process development activities related to our combination drug-device platforms. This role contributes to the design, optimization, and validation of innovative medical devices, ensuring alignment with quality, regulatory, and clinical requirements while mentoring junior engineers.

Key Accountabilities

• Lead the 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.

Qualifications

Required Qualifications

• Bachelor’s degree in Mechanical, Biomedical, or Chemical Engineering.
• 5+ years of R&D or 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.

Preferred Qualifications

• Experience with drug-device combination products or interventional cardiology devices.
• Advanced degree (M.S. or Ph.D.) in engineering or related discipline.
• Knowledge of polymer coatings, drug release kinetics, or sterilization processes.

Key Competencies

• Technical innovation and problem-solving ability.
• Excellent documentation and communication skills.
• Strong leadership and mentoring skills.
• Collaboration and cross-functional influence.
• Commitment to quality and regulatory compliance.

Working Conditions

• Office and laboratory environments.
• May require standing or bending for extended periods.
• Light lifting (up to 25 lbs.).
• Occasional travel (<10%) to suppliers or test facilities.