Senior R&D Process Development Engineer – Scale-Up

Merit Medical Systems; Galway; Hybrid; EUR 70,000 - 100,000; Full time

Benefits offered by this job

Health Insurance

Life assurance

Free Parking

Educational assistance

Internal training courses

Career progression opportunities

Job summary

Merit Medical Galway is seeking an experienced R&D Process Development Engineer to join our dynamic R&D group. The role focuses on selecting, generating and validating new process technologies and advancing existing methods, ensuring robust, scalable solutions for manufacturing.

You will lead a core R&D team, collaborate across groups, and drive manufacturability, cost and quality considerations from concept through qualification in a global medtech environment.

Qualifications

• Degree in Engineering or related technical field.
• At least 5 years of related experience.
• Demonstrated ability in analytical problem solving, process development, validation and statistical analysis.
• Experience in metal processing & joining techniques; emerging process technologies is advantageous.
• Good working knowledge of vascular medical device materials and regulatory requirements.
• Working knowledge of SolidWorks and/or 3D modeling.
• Demonstrated people and team management skills.
• Formal project management training is an advantage.
• Strong interpersonal and organizational skills and ability to work effectively as a team member and leader.

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.

Skills

Process development

Analytical problem solving

Statistical analysis

Team leadership

Problem solving

Vendor selection

Education

Engineering degree

Tools

SolidWorks

3D modeling

Job description

Merit Medical Galway is seeking an experienced R&D Process Development Engineer to join our dynamic R&D group. The role focuses on selecting, generating and validating new process technologies and advancing existing methods, ensuring robust, scalable solutions for manufacturing.

You will lead a core R&D team, collaborate across groups, and drive manufacturability, cost and quality considerations from concept through qualification in a global medtech environment.