NPD Engineer II - Medical Catheter Innovations

Quasar Medical | Medical Device Manufacturer; Galway; On-site; EUR 60,000 - 90,000; Full time

Job summary

Quasar Medical, a medical-device manufacturer in Ireland, seeks an NPD Engineer II to drive development and commercialisation of catheter-based devices. You will lead technical workstreams from feasibility to manufacturing transfer, coordinating with manufacturing, quality, and supply chain.

You will design robust product solutions, manage risk, and deliver design verifications, validations, and documents to support regulatory approvals and product launches.

Qualifications

• Level 8 bachelor’s degree in Mechanical, Biomedical, Manufacturing, or a related technical discipline.
• 3 to 5 years’ relevant engineering experience in medical-device product development, manufacturing engineering, or a similar regulated industry.
• Experience in product and process development, including prototype builds, engineering testing, technical problem-solving and transfer to manufacturing.
• Experience working within a regulated quality system, with practical knowledge of design controls, risk management, verification, validation and technical documentation.
• Demonstrated ability to independently plan and deliver assigned engineering activities, analyse technical data and develop evidence-based solutions.
• Experience with balloon catheters, braided shafts, delivery systems or other minimally invasive medical devices is highly desirable.

Responsibilities

• Design and develop catheter-based medical devices, translating customer and product requirements into practical, manufacturable solutions.
• Develop and optimise product designs, materials, manufacturing processes, tooling, fixtures and test methods from feasibility through commercialisation.
• Plan and execute prototype builds, engineering trials, process development, testing and technical investigations, applying appropriate engineering, statistical and experimental methods.
• Generate and maintain design and development documentation in accordance with applicable quality-system and design-control requirements, including specifications, drawings, protocols, reports, risk documentation and manufacturing instructions.
• Support design reviews, risk management, design verification and validation, process validation and design transfer, ensuring appropriate traceability of requirements and supporting evidence.
• Analyse product and process performance, investigate failures and technical issues, identify root causes, and develop appropriate corrective or risk-mitigation actions.
• Develop manufacturing processes and controls capable of consistently meeting product, customer, quality and regulatory requirements.
• Lead assigned technical activities through manufacturing transfer, pilot builds, validation, production launch and early commercial manufacture, working closely with Operations, Quality and Supply Chain.
• Deliver assigned engineering activities against agreed project scope, timelines, budget and quality requirements, proactively identifying and escalating technical risks, issues and dependencies.

Skills

Problem solving

Analytical thinking

Documentation

Cross-functional collaboration

Regulatory awareness

Education

Bachelor’s degree in Mechanical, Biomedical, Manufacturing or related technical discipline

Job description

Quasar Medical, a medical-device manufacturer in Ireland, seeks an NPD Engineer II to drive development and commercialisation of catheter-based devices. You will lead technical workstreams from feasibility to manufacturing transfer, coordinating with manufacturing, quality, and supply chain.

You will design robust product solutions, manage risk, and deliver design verifications, validations, and documents to support regulatory approvals and product launches.