Operations Engineer II- Medical Device Start-up

Wallace Myers International; Galway; On-site; EUR 50,000 - 70,000; Full time

Job summary

A medical device recruiting firm seeks an Operations Engineer II to optimize and scale manufacturing operations for a next-generation medical device. The ideal candidate will have 3+ years in operations engineering and experience with new product introduction. This position offers opportunities for growth in a collaborative start-up environment in Galway.

Benefits

Opportunity to join a growing medical device start-up

Exposure to end-to-end product lifecycle

Qualifications

• 3+ years experience in medical device manufacturing or operations engineering.
• Experience supporting New Product Introduction (NPI) and process validation activities.
• Hands-on experience with equipment qualification in a regulated environment.

Responsibilities

• Lead manufacturing process development for medical devices.
• Partner with R&D, Quality, and Supply Chain for NPI support.
• Develop manufacturing processes and work instructions.

Skills

Manufacturing process controls

Root cause analysis

Lean manufacturing

Communication skills

Process validation

Continuous improvement methodologies

Education

Bachelor's Degree in Engineering

Tools

DFSS

Six Sigma

Job description

Operations Engineer II- Medical Device Start-up

Permanent

Galway

Job Title: Operations Engineer II- Medical Device start-up

Position Overview
The Operations Engineer II will play a key role in establishing, optimising, and scaling manufacturing operations for a next-generation medical device.
Working within a cross-functional environment, this position involves supporting New Product Introduction (NPI), process development, and manufacturing readiness to ensure robust, compliant, and efficient production processes.

Key Responsibilities

• Lead and support manufacturing process development, optimisation, and validation for new and existing medical device products.
• Partner with R&D, Quality, and Supply Chain to support NPI and design transfer into manufacturing.
• Develop and document manufacturing processes, work instructions, and test procedures to ensure consistent product quality and compliance.
• Plan and execute process validation activities (IQ/OQ/PQ) and associated documentation.
• Identify and implement process improvements to enhance yield, reduce cost, and increase efficiency.
• Support the introduction of new equipment, tooling, and fixtures, including qualification and calibration activities.
• Drive root cause analysis and CAPA initiatives to resolve manufacturing or quality issues.
• Ensure all operations comply with relevant QMS requirements, ISO 13485, and FDA 21 CFR Part 820 regulations.
• Collaborate with internal and external partners (including suppliers and contract manufacturers) to ensure effective scale‑up and production readiness.
• Support manufacturing during audits and inspections as an SME for assigned processes.
• Mentor and provide technical guidance to junior team members or technicians as required.

Qualifications & Experience
Essential:

• Bachelor's Degree in Engineering (Manufacturing, Mechanical, Biomedical, or related discipline).
• Minimum of 3 years' experience in a medical device manufacturing or operations engineering role.
• Proven experience supporting New Product Introduction (NPI) and process validation activities.
• Strong understanding of manufacturing process controls, root cause analysis, and risk management.
• Hands‑on experience with process validation, equipment qualification, and documentation within a regulated environment.
• Proficiency in lean manufacturing and continuous improvement methodologies.
• Strong communication and interpersonal skills with the ability to work cross‑functionally in a fast‑paced, team‑oriented environment.
• Experience working with vascular, catheter-based, or electromechanical devices.
• Familiarity with DFSS, Six Sigma, or similar process improvement tools.
• Previous experience in a start‑up or scale‑up medical device environment.

What's on Offer

• Opportunity to join a growing medical device start‑up developing novel vascular technologies.
• Exposure to end-to-end product lifecycle, from concept through to commercial manufacturing.
• Collaborative and innovative work culture with opportunities for professional growth.