Position Summary: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.
Primary 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
Requirements:- BS in Engineering, Materials Science, Chemistry, Chemical Engineering, or related field
- Minimum of 4 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
Key benefits we provide:
- Medical, Dental, Vision insurance
- Generous Paid Time Off (PTO)
- Paid Parental Leave
- Paid Holidays
- 401k Plan (with a generous employer match)
- Life Insurance (company paid)
- Short-Term & Long-Term Disability Insurance (company paid)
- Subscription to Calmhealth.com
- Employee Assistance Program
- An environment of belonging where everyone can thrive
