New Product Design & Development Quality Lead

Integer; Galway; On-site; EUR 45,000 - 65,000; Full time

Job summary

Integer in Galway seeks a New Product Design & Development Quality Engineer to lead quality assurance, control and preventive activities across the product lifecycle. You will guide NPI initiatives, cooperate with cross-functional teams and ensure compliance with medical device standards.

This role involves developing test strategies, supporting risk assessments, and mentoring engineers to drive continuous improvement and successful product launches.

Qualifications

• Degree in Engineering/Science (1-3 years’ experience).
• Knowledge of ISO 13485:2016 and medical device manufacturing.

Responsibilities

• Provide quality engineering support for new product introduction, design transfer and product release.
• Support the implementation and improvement of NPI processes and Lean Product Development practices.
• Develop and review test strategies, protocols, reports and verification and validation documentation.
• Support risk assessments and product lifecycle change management.
• Support validation activities throughout the product realization process.
• Ensure quality requirements are addressed across development and manufacturing.
• Collaborate with project teams and customers to resolve quality issues and deliver projects that meet or exceed expectations.
• Apply structured problem-solving and risk-based approaches to investigate issues and implement corrective actions.
• Provide technical guidance, coaching and mentoring to engineers and technicians.
• Collaborate with cross-functional teams to support successful product launches and manufacturing releases.

Skills

Quality engineering

NPI processes

Risk management

Mentoring

Cross-functional teamwork

Education

Bachelor's degree in Engineering or Science

Job description

Integer in Galway seeks a New Product Design & Development Quality Engineer to lead quality assurance, control and preventive activities across the product lifecycle. You will guide NPI initiatives, cooperate with cross-functional teams and ensure compliance with medical device standards.

This role involves developing test strategies, supporting risk assessments, and mentoring engineers to drive continuous improvement and successful product launches.