Senior R&D Process Development Engineer

Merit Medical Systems, Inc.

Galway

On-site

EUR 70,000 - 100,000

Full time

17 hours ago

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Benefits offered by this job

Attractive Salary package

Defined Contribution Pension Plan

Health Insurance Cover

Life assurance

Health & Wellbeing Events Calendar

Excellent career progressionopportunit

Recognition scheme

Free Parking

Educational assistance

Internal training courses

Quality Subsidised Canteens & Barista

Active Sports and Social Club

Job summary

Merit Medical Galway seeks an R&D Process Development Engineer to join our R&D group. You will lead process tech development, select and validate new technologies, and ensure robust solutions from equipment to testing are transfer-ready for manufacturing.

The role collaborates with project leaders and operations to meet product requirements, while mentoring engineers and technicians to build a high-performance team and deliver compliant, scalable processes.

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

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.