Senior NPD Engineer.

Senior NPD Engineer

Location: Galway, Ireland

Reports To: Director, NPD

Type: Full-time

Our client, a leading medical device manufacturer, is seeking a Senior NPD Engineer to provide technical leadership for development programs throughout the NPD lifecycle. Acting as technical lead, you'll be responsible for engineering execution and technical decision-making, ensuring products are developed in accordance with customer, regulatory, quality, and manufacturing requirements. You'll serve as the primary technical interface with customers, leading technical discussions, design reviews, and problem-solving activities, while partnering with the Program Manager on project planning, budgeting, and risk management. The role also provides leadership, coaching, and mentoring to engineers and technicians, and may carry direct people management responsibility.

Key Responsibilities

• Lead the technical execution of product development programs from feasibility through manufacturing transfer.
• Act as the primary technical interface with customers, building strong relationships and providing technical leadership throughout the development process.
• Lead technical reviews, design reviews, risk assessments, and problem-solving activities with customers and internal teams.
• Own technical strategy, design decisions, and engineering execution for assigned projects.
• Ensure products and associated processes are developed in accordance with customer requirements, Design Controls, regulatory standards, and business objectives.
• Partner with Program Managers on project planning, budgeting, resource allocation, and risk management.
• Identify, assess, and mitigate technical risks throughout the product development lifecycle.
• Drive development activities through verification, validation, design transfer, and commercialisation.
• Collaborate with customers and internal stakeholders (Manufacturing, Quality, Supply Chain) to achieve successful project outcomes.
• Support manufacturing scale-up, product transfer, and post-commercialisation activities.
• Provide leadership, coaching, and technical guidance to engineers and technicians; may have direct people management responsibility.
• Maintain accurate technical documentation and development records throughout all stages of product development.

Qualifications & Experience

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Polymer Engineering, or a related discipline.
• Minimum 7 years of medical device product development experience.
• Demonstrated experience leading development projects throughout the product development lifecycle.
• Experience working within Design Control and regulated medical device environments.
• Proven customer-facing experience with responsibility for technical discussions and project leadership.
• Experience leading, mentoring, or managing engineers and technical teams.
• Working knowledge of Design Controls, Risk Management, Verification & Validation, and Design Transfer.
• Knowledge of applicable medical device regulations and standards, including ISO 13485 and FDA requirements.
• Experience with catheter-based, balloon catheter, or delivery system technologies is an advantage.

For further information on this role please contact Gavin Moran on 087 4108620 or [email protected] Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/ Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval. Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review your application.