R&D Engineer (Coatings)

Our mission is to save lives. Scientia Vascular is aleading innovator and manufacturer of endovascular medical devices. We usemicromachining and microfabrication processes to manufacture products thatprovide physicians with enhanced performance for optimal outcomes for theirpatients.

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 weprovide:

• 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
• Employee Assistance Program
• An environment of belonging where everyone can thrive

Commitment toEqual Opportunity:

The Scientia Vascular culture iscentered on the principals of equal opportunity for all employees. Consistentwith our culture all qualified applicants will receive consideration foremployment without regard to race color religion gender gender identity orexpression family status marital status sexual orientation national origingenetics disability age or veteran status or any other non-merit based orlegally protected grounds.

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