R&D Engineer (Coatings)

About the role

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. 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.

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
• 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

Qualifications

• 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

Skills

• 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

Benefits

• 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

Pay

TBD

Schedule

TBD