R&D Process Development Engineer III

Merit Medical Systems, Inc.; Galway; On-site; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Health Insurance

Defined Contribution Pension Plan

Life assurance

Free Parking

Educational assistance

Internal training courses

Job summary

Merit Medical Galway is seeking an experienced R&D Process Development Engineer to join the R&D group. This hands-on role focuses on selecting, generating and validating new process technologies and advancing existing methods for seamless transfer into scale manufacturing.

The ideal candidate has engineering training, 5+ years of related experience, and strong skills in process development, validation, statistics and design for manufacturability.

Qualifications

• Degree in Engineering or related technical field with demonstrated experience.
• At least 5 years of relevant industry experience.
• Experience with process development, validation and process qualification activities.

Responsibilities

• Collaborate with Project Leaders, R&D, Operations to understand product requirements and deliverables.
• Lead and develop Engineers and Technicians to build a high-performance team.
• Select and develop materials, vendors and technologies for robust process designs.
• Design and develop production equipment, tooling and fixtures for new products.
• Collaborate with internal and external teams to refine fixtures and equipment.
• Ensure manufacturability, cost and capacity considerations for scale-up.
• Define drawings, BOMs, routers and procedures for manufacturing transfer.
• Document all equipment and fixturing with tolerances and maintenance plans.
• Plan risk assessments, process specs, test methods, and IQ/OQ/PQ qualifications.
• Maintain Engineering and Design documentation per QMS and regulatory standards.
• Mentor Junior Engineers and Technicians.
• Perform related duties as required.

Skills

Analytical problem-solving

Process development

Statistical analysis

People management

Project management

Team leadership

Interpersonal skills

Education

Engineering degree

Tools

Solidworks

3D modeling

Job description

Why Merit?

At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.

SUMMARY OF DUTIES

Due to continuous growth at our Galway site, an opportunity now exists for an R&D Process Development Engineer to join our R&D group.
This exciting opportunity is a key role within R&D and will take a hands‑on role in the selection, generation and validation of new process technologies and the further development of existing processing methods. The Process Development Engineer will be a key member of the Product Development Core Team focusing on all process related aspects to ensure the generation and implementation of robust solution from a systems, Equipment and test perspective that will seamlessly transfer in to scale manufacturing.

DUTIES & RESPONSIBILITIES

• Liaise with Project Leaders, R&D, Operations and other internal stakeholders to clearly understand product requirements, process inputs and project deliverables.
• Lead by example, set standards and provide direction, coaching and development to Engineers and Technicians to build a high‑performance, high‑capability team.
• Investigate, select and develop appropriate materials, vendors, technologies and specifications to ensure process designs are robust, reproducible and capable of meeting all qualification and regulatory requirements.
• Design and develop production equipment, tooling and fixtures to support new product and process introduction, generate detailed engineering drawings and specifications, and work closely with vendors to ensure equipment is manufactured and delivered to defined technical, quality and project requirements.
• Collaborate with internal teams and external suppliers to specify, prototype and refine custom fixtures and equipment that support consistent assembly, measurement, handling and testing of components.
• Ensure Design for Manufacturability, capacity planning and product cost impacts are considered in all decision‑making such that designs can be scaled seamlessly into manufacturing at the required product cost.
• Define and implement drawings, BOMs, routers and procedures to ensure product design is accurately translated into manufacturing operations.
• Ensure all equipment and fixturing designs are fully documented, including drawings, tolerances, materials and maintenance plans, and integrated into overall process flows and qualification strategies.
• Plan and execute risk assessments, process specifications, test method development and subsequent Process Qualifications (IQ, OQ, PQ).
• Generate and maintain Engineering and Design documentation in accordance with the Quality Management System and applicable regulatory standards.
• Manage and provide guidance and development to Junior Engineers and Technicians.
• Perform other related duties and tasks as required.

SUMMARY OF MINIMUM QUALIFICATIONS

• Degree in Engineering, related technical field or with appropriate demonstrated experience.
• At least 5 years previous related experience.
• Demonstrated ability in analytical problem-solving, Process development, validation and statistical analysis.
• Experience in Metal processing & joining techniques and emerging process technologies an advantage.
• Good working knowledge of vascular medical device materials and processes and regulatory requirements.
• Working knowledge of Solidworks and / or 3D modeling.
• Demonstrated People/team management skills.
• Formal project management training an advantage.
• Strong interpersonal and organizational skills and the ability to work effectively as a team member and leader

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Key Benefits

• Attractive Salary package
• Defined Contribution Pension Plan
• Health Insurance Cover
• Life assurance
• Health & Wellbeing Events Calendar
• Excellent career progression opportunities
• Recognition scheme
• Free Parking
• Educational assistance
• Internal training courses
• Quality Subsidised Canteens & Barista Service
• Active Sports and Social Club

We are Global

Merit Medical Galway commenced with 22 employees in 1993. Since then Merit has enjoyed year on year revenue growth and developed its workforce to over 900 employees. Headquartered in Salt Lake City, Utah, Merit maintains a diverse, multi-campus manufacturing footprint in Europe, North America, South America, Asia and Australia with a global distribution.

Medtech Company of the Year Winner

Merit Medical Galway are proud winners of the Medtech Company of the Year Award, a prestigious award recognizing those who are exceling in the MedTech industry.

People Development

At Merit Medical Galway almost 60% of all roles are filled by internal employees! We focus on encouraging, believing in and providing a platform for you to progress your career!

Culture

A supportive and collaborative environment make Merit Medical a friendly, enjoyable place to work. We are proud of our energetic and dynamic culture. Diversity & Inclusion is evident here with an 50/50 ratio of male and female employees as well as 30 nationalities onsite! We value every employee as an individual.

To see more on our culture, go to www.merit.com/careers.