Senior R&D Engineer
cordisIrvine, CA
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 QualificationsBachelor’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 (
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