Senior Medical Device NPD Engineer – Lead, Galway

HERO Recruitment Ltd.; Galway; On-site; EUR 90,000 - 120,000; Full time

Job summary

HERO Recruitment Ltd. represents a leading medical device manufacturer in Galway, Ireland, seeking a Senior NPD Engineer to provide technical leadership across the NPD lifecycle.

You will act as the primary technical interface with customers, lead design reviews and risk assessments, and mentor engineers and technicians.

The role requires a Bachelor's in related engineering, 7+ years of device development experience, and familiarity with Design Controls, ISO 13485, and FDA requirements.

Qualifications

• Bachelor’s degree in a related engineering field.
• Minimum 7 years of medical device product development experience.
• Experience leading development projects across the product lifecycle.
• Experience with Design Controls and regulated medical environments.
• Evidence of customer-facing technical leadership and problem solving.
• Experience mentoring engineers and teams.
• Knowledge of ISO 13485 and FDA requirements.
• Experience with catheter-based, balloon catheter, or delivery system tech is advantageous.

Responsibilities

• Lead technical execution of product development from feasibility through manufacturing transfer.
• Act as the primary technical interface with customers, building relationships and providing leadership.
• 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 processes comply with 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 lifecycle.
• Drive development activities through verification, validation, design transfer, and commercialization.
• Collaborate with customers and internal stakeholders to achieve successful project outcomes.
• Provide leadership and mentoring to engineers and technicians; may have people management responsibility.

Skills

Leadership

Customer-facing

Mentoring

Education

Bachelor’s degree in Mechanical Engineering; Biomedical/Polymer Engineering or related

Job description

HERO Recruitment Ltd. represents a leading medical device manufacturer in Galway, Ireland, seeking a Senior NPD Engineer to provide technical leadership across the NPD lifecycle.

You will act as the primary technical interface with customers, lead design reviews and risk assessments, and mentor engineers and technicians.

The role requires a Bachelor's in related engineering, 7+ years of device development experience, and familiarity with Design Controls, ISO 13485, and FDA requirements.