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.
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