Senior Medical Device NPD Engineer — Technical Leader

Sterling Engineering Ltd - Ireland & Europe; Galway; On-site; EUR 90,000 - 120,000; Full time

Job summary

Sterling Engineering Ltd - Ireland & Europe is seeking an experienced Senior NPD Engineer to lead early and late-stage medical device development projects. You will own technical direction from feasibility through to verification, validation, transfer and commercialisation, while collaborating with customers and cross-functional teams.

The role requires a Bachelor’s degree in a relevant engineering field, 7+ years in medical device product development, strong experience with Design Controls, ISO

Qualifications

• 7+ years' experience in medical device product development.
• Proven experience leading new product development programmes through multiple stages of the product development lifecycle.
• Experience working within Design Control and regulated medical device environments.
• Technical leadership and customer-facing roles, including leading technical discussions and design reviews.
• Experience mentoring engineers and technical teams.
• Knowledge of ISO 13485 and FDA requirements.
• Excellent technical communication, presentation and problem-solving abilities.
• Ability to lead cross-functional teams and influence stakeholders at different levels.
• Understanding of project planning, budgeting, resource allocation and risk management.

Responsibilities

• Lead the technical execution of new product development programmes from feasibility through to manufacturing transfer and commercialisation.
• Act as the primary technical point of contact for customers, developing strong relationships and leading technical discussions and design reviews.
• Own technical strategy, engineering decisions and execution across assigned projects.
• Lead design reviews, technical assessments, risk management activities and structured problem-solving initiatives.
• Ensure products and associated manufacturing processes are developed in line with customer requirements, Design Controls, regulatory requirements, quality standards and business objectives.
• Work closely with ProgrammeManagers on project planning, budgets, resource requirements, timelines and risk management.
• Provide technical input into project budgets and ensure engineering activities are delivered within agreed project constraints.
• Identify, assess and mitigate technical risks throughout the product development lifecycle.
• Drive engineering activities through verification, validation, design transfer and commercialisation.
• Collaborate closely with customers and internal functions including Manufacturing, Quality and Supply Chain to deliver successful project outcomes.
• Support manufacturing scale-up, product transfer and post-commercialisation activities.
• Contribute to feasibility studies, rapid prototyping and technology development initiatives.
• Provide technical leadership, coaching and mentoring to engineers and technicians, with potential responsibility for direct people management.
• Promote a culture of technical excellence, accountability, collaboration and continuous improvement.
• Maintain accurate technical documentation and development records throughout the product lifecycle.
• Ensure all engineering activities comply with company procedures, Quality System requirements and applicable medical device regulations and standards.

Skills

Technical leadership

Customer-facing

Communication

Problem solving

Mentoring

Education

Bachelor's degree in Mechanical Engineering or Biomedical/Polymer Engineering

Job description

Sterling Engineering Ltd - Ireland & Europe is seeking an experienced Senior NPD Engineer to lead early and late-stage medical device development projects. You will own technical direction from feasibility through to verification, validation, transfer and commercialisation, while collaborating with customers and cross-functional teams.

The role requires a Bachelor’s degree in a relevant engineering field, 7+ years in medical device product development, strong experience with Design Controls, ISO