Senior New Product Development Engineer

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

We are currently recruiting for an experienced Senior NPD Engineer to join a growing medical device organisation and play a key technical leadership role across new product development programmes.

This is an excellent opportunity for an experienced product development engineer who enjoys taking ownership of technically complex projects, working directly with customers and leading multidisciplinary teams through the full product development lifecycle.

As Senior NPD Engineer, you will act as the technical lead for assigned development programmes, providing engineering direction from initial feasibility and concept development through verification and validation, design transfer and commercialisation.

You will work closely with customers, programme management and cross functional internal teams to ensure products are developed to the required technical, regulatory, quality and manufacturing standards.

Key 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.

Experience / Background

• A Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Polymer Engineering or a related discipline.
• 7+ years' experience in medical device product development.
• Proven experience leading new product development programmes through multiple stages of the product development lifecycle.
• Strong experience working within Design Control and regulated medical device environments.
• Demonstrable experience in technical leadership and customer-facing roles, including leading technical discussions and design reviews.
• Experience leading, mentoring or managing engineers and technical teams.
• Knowledge of applicable medical device regulations and standards, including ISO 13485 and FDA requirements.
• Excellent technical communication, presentation and problem-solving abilities.
• The ability to lead cross-functional teams and influence stakeholders at different levels.
• An understanding of project planning, budgeting, resource allocation and risk management.
• Strong organisational skills and attention to detail.
• A high level of integrity, professionalism and accountability.