Quality Engineer II

An innovative, growing medical device company in Galway is seeking a Quality Engineer II to support process quality and design assurance across the development and manufacture of patient-focused medical devices. Working closely with R&D, Clinical, Regulatory and Manufacturing Engineering teams, you will help ensure a robust transition from design through to production. The seniority of the position may be tailored to the successful candidate's experience.

Key Responsibilities

• Support the transfer of design activities into manufacturing, including dFMEA to pFMEA, design specifications to manufacturing specifications, and design test methods to process test methods.
• Support design verification and validation testing, including associated test methods.
• Plan and support product builds for R&D testing, product verification, clinical trials and commercial use alongside R&D colleagues.
• Lead the transfer of an electromechanical medical device assembly line, supported by the Project Manager and Quality Director.
• Support equipment, process and test method validation activities.
• Collaborate with external manufacturing partners and suppliers.
• Identify and implement opportunities for process optimisation and improved manufacturability.
• Engineering, scientific or technical qualification (including ASQ CQE).
• At least 3 years of engineering experience in a manufacturing environment.
• Experience working within an ISO 13485 quality management system or equivalent regulated environment.
• Experience improving processes with design for manufacturability (DFM) considerations.
• Experience installing and validating equipment, processes or test methods.
• Strong problem-solving and root-cause investigation skills.
• Ability to use statistical tools and proficiency with MS Excel and Word.
• Strong communication skills and confidence engaging with internal and external stakeholders.
• Lead Auditor certification.
• Experience with PCBs, electrical components, electromechanical assemblies or polymeric components.
• Process validation and assembly line transfer experience.
• Experience in a start-up or SME environment.
• Experience training or developing colleagues.

What's on Offer

A competitive salary and flexible benefits package, flexible working hours, generous annual leave, and opportunities for training and professional development in a collaborative, fast-moving medical device environment.