R&D Process Development Engineer

About Merit Medical

Merit Medical Systems, Inc. is dedicated to designing innovative medical devices that enhance patient care worldwide. Our commitment is to hire and nurture individuals who thrive on dedication, teamwork, and creating impactful solutions. Together, we strive to positively affect lives globally.

Role Overview

Due to expansion at our Galway facility, we are seeking an R&D Process Development Engineer to join our Research & Development division. This critical role involves hands-on involvement in selecting, developing, and validating advanced process technologies and refining current processing methods. As an integral member of the Product Development Core Team, you will concentrate on all process-related aspects ensuring the delivery and implementation of reliable solutions from systems, equipment, and testing perspectives that transition seamlessly into scalable manufacturing.

Key Duties and Responsibilities

• Collaborate closely with Project Leaders, R&D, Operations, and other internal teams to deeply understand product specifications, process parameters, and project goals.
• Lead by example by establishing standards, providing guidance, and mentoring engineers and technicians to cultivate a high-performing and skilled team.
• Research, identify, and develop suitable materials, suppliers, technologies, and process specifications that ensure robustness, consistency, and compliance with qualification and regulatory mandates.
• Engineer production equipment, tooling, and fixtures to facilitate new product launches and process introductions; generate detailed engineering documentation; and coordinate with vendors to guarantee equipment delivery aligns with technical, quality, and project expectations.
• Work with internal groups and external vendors to design, prototype, and perfect specialized fixtures and equipment that support uniform assembly, measurement, handling, and testing procedures.
• Incorporate Design for Manufacturability principles, capacity planning, and cost impact assessments in all decisions to ensure solutions can be scaled efficiently with controlled product costs.
• Define and implement accurate drawings, bills of materials, routing instructions, and procedures to ensure seamless translation of product designs into manufacturing workflows.
• Maintain comprehensive documentation for all equipment and fixture designs, including technical drawings, tolerances, materials, and maintenance plans, integrated within overarching process flows and qualification strategies.
• Plan and carry out risk assessments, define process specifications, develop test methods, and conduct process qualifications including IQ, OQ, PQ phases.
• Manage engineering and design documentation in accordance with quality management systems and regulatory requirements.
• Provide leadership, mentorship, and development for junior engineers and technical staff.
• Undertake additional related duties as assigned.

Minimum Qualifications and Experience

• Degree in Engineering or a relevant technical discipline, or comparable demonstrated experience.
• A minimum of 4 years of relevant experience in process development.
• Proven analytical problem-solving abilities, process development expertise, validation, and application of statistical analysis techniques.
• Experience with metal processing and joining techniques and knowledge of emerging process technologies is advantageous.
• Familiarity with vascular medical device materials, manufacturing processes, and regulatory compliance standards.
• Competency in SolidWorks and/or 3D modeling software.
• Demonstrated leadership and team management capabilities.
• Project management certification or formal training is beneficial.
• Strong interpersonal communication, organizational skills, and the ability to function effectively both as a team member and a leader.

Benefits and Perks

• Competitive salary package.
• Participation in a Defined Contribution Pension Plan.
• Comprehensive health insurance coverage.
• Life assurance policy.
• Health and wellbeing programs and events.
• Opportunities for career growth and advancement.
• Employee recognition schemes.
• Complimentary parking facilities.
• Educational support programs.
• Internal professional development and training courses.
• Quality subsidized canteens along with barista services.
• Active sports and social club fostering community spirit.

Company Culture and Growth

Merit Medical Galway started with 22 employees in 1993 and has since expanded steadily to over 900 employees. As part of a global enterprise headquartered in Salt Lake City, Utah, the company operates multiple campuses across Europe, North America, South America, Asia, and Australia with an extensive global distribution network. Recognized as the Medtech Company of the Year, Merit Medical fosters a supportive, dynamic work environment emphasizing diversity, inclusion, and equal gender representation. Nearly 60% of roles are filled internally, reflecting a strong commitment to employee development and career progression.