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 …
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 …
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Full-time
bachelor degree, postgraduate degree
Posted 2d ago
Apply by Sep 9
~40 hrs/week
Responsibilities
The Senior R&D Engineer leads the design, development, and testing of combination drug-device platforms while ensuring compliance with regulatory standards. They also provide technical oversight for technology transfer and mentor junior engineering staff.
Requirements
Candidates must hold a bachelor's degree in Mechanical, Biomedical, or Chemical Engineering with at least 5 years of R&D experience in the medical device industry. Proficiency in design controls, risk management, and CAD software is required.
Full 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.
Related keywords
R&DMedical DevicesDrug-coated Balloon CathetersDesign ControlsFDA 21 CFR Part 820ISO 13485SolidWorksCADRisk ManagementVerification and ValidationTechnology TransferProcess Scale-upRegulatory SubmissionsFMEAPolymer CoatingsDrug Release Kinetics
From the first guidewire to the first drug eluting stent, for over 60 years Cordis has remained at the heart of cardiovascular innovation. Cordis is again at the forefront of transformation in the cardiovascular space, leveraging internal development, partnership with the CordisX innovation incubator and targeted acquisitions of industry-disrupting technology. These innovations, brought to market with the strength of Cordis’ global footprint and operations, seek to transform the interventional space through enhanced clinical outcomes, customer-centric services, and impactful educational platforms – doubling-down on our commitment to the interventional community. Cordis will Go Beyond, to relentlessly pursue our dedication to transform cardiovascular care.
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