Process Engineer - Medical Device

OverviewWho we arePM Group is an employee owned, international project delivery firm with a team of 3,700 + people. We are world leaders in the pharma, food, medtech and mission critical sectors. From our network of offices in Europe, Asia and the US, we work with the world's leading organisations. We are focused on growing a sustainable business centred around our people, our clients and trade partners.We are seeking a skilled Process Engineer to join one of our global clients based in South Dublin. The successful candidate will be responsible for developing, and maintaining manufacturing processes to ensure compliance with regulatory standards and deliver high-quality medical devices.ResponsibilitiesKey ResponsibilitiesDesign, implement, and improve manufacturing processes for medical device production.Conduct root cause analysis and implement corrective actions for process-related issues.Collaborate with cross-functional teams (Quality, R&D, Operations) to support new product introductions.Ensure compliance with ISO 13485, FDA, and other relevant regulatory requirements.Develop and maintain process documentation, including SOPs and validation protocols.Drive continuous improvement initiatives using Lean and Six Sigma methodologies.QualificationsQualifications & SkillsBachelor’s degree in Engineering (Mechanical, Manufacturing, Biomedical, or related field).4+ years of experience in a regulated manufacturing environment (medical devices preferred).Strong knowledge of process validation, risk analysis, and regulatory compliance.Proficiency in Lean/Six Sigma tools and methodologies.Excellent problem-solving and analytical skills.Strong communication and teamwork abilities.As an employee-owned company, we are inclusive, committed and driven. Corporate Responsibility and Sustainability are the heart of our new 2025 business strategy.Inclusion and Diversity are core to our culture and values. Wherever we work, we commit to a culture of mutual respect and belonging by building a truly inclusive workplace rich in diverse people, talents and ideas. Valuing the contributions of all our people and respecting individual differences will sustain our growth into the future.PM Group is committed to ensuring our hiring process is fair and accessible to all and will provide candidates with disabilities with reasonable accommodations required to participate in the recruitment process. If you require any assistance in this regard, please let us know.