R&D Engineer

SCIENTIA VASCULAR INC•West Valley City, UT

About The Position

Responsible for the research, design, development, and optimization of hydrophilic coating systems for medical devices. This role will lead and contribute to cross-functional development teams supporting coating formulation, surface preparation, application processes, scale-up, and verification/validation activities. The position will work with general direction and exercise significant technical judgment in solving complex materials, process, and performance challenges related to hydrophilic coatings.

Requirements

BS in Engineering, Materials Science, Chemistry, Chemical Engineering, or related field
5–7 years of medical device R&D experience, including hydrophilic or lubricious coatings
Proven track record of developing and launching coated medical devices into production
Strong knowledge of polymer chemistry, surface science, and coating adhesion mechanisms
Hands-on experience with coating application, curing, and process optimization
Experience with medical device design controls and regulatory requirements (FDA, ISO)
Demonstrated ability to develop and validate test methods and statistically analyze data
Experience supporting scale-up, technology transfer, and manufacturing readiness
Familiarity with biocompatibility requirements for coated devices
Strong written and verbal communication skills
Proficient in Microsoft Excel and Word for data analysis and reporting

Responsibilities

Lead and support R&D for hydrophilic coatings on medical devices, including new product development and lifecycle improvements
Design, develop, and optimize coating formulations, surface treatments, and application processes (dip, spray, UV/thermal cure)
Evaluate coating performance (lubricity, durability, adhesion, thickness, uniformity, aging, biocompatibility) using bench and in-vitro testing
Plan and execute research investigations, including bench and animal studies, to support coating performance and clinical use
Select, characterize, and qualify substrates, primers, polymers, solvents, and additives compatible with hydrophilic coating systems
Develop, validate, and maintain test methods for coating characterization and performance
Design and execute process development, scale-up, and manufacturing transfer studies
Build prototypes and coated components; translate early concepts into robust, manufacturable processes
Troubleshoot coating, material, and process issues related to defects, variability, or field performance
Plan and coordinate verification and validation (V&V) testing; author technical reports supporting regulatory submissions
Generate and maintain design control documentation, specifications, protocols, and reports in compliance with FDA and international regulations
Contribute to intellectual property through invention disclosures related to coating chemistry, processes, or applications
Design or specify coating and test tooling, fixtures, and equipment
Maintain accurate laboratory notebooks documenting experiments, formulations, processes, and results
Collaborate with process development, manufacturing, quality, regulatory, clinical, and marketing teams to support commercialization
Provide technical support for fielded products, including complaint investigations and case support
Train and mentor technicians or junior engineers as needed
Perform other duties as assigned, with or without accommodation