Senior Medical Device Process Engineer - Scale & Innovate

AMA Consulting Group LLC; Galway; On-site; EUR 55,000 - 75,000; Full time

Job summary

A leading medical device company in Galway, Ireland, seeks a Senior Process Development Engineer. This role focuses on designing and validating manufacturing processes to ensure device safety and compliance. The ideal candidate has over 5 years of experience, a Level 8 engineering degree, and expertise in Lean principles and regulatory standards. Responsibilities include collaborating with production teams, leading automation initiatives, and driving process improvements. This position offers an opportunity to impact operational excellence in a dynamic industry.

Qualifications

• 5+ years of relevant experience in medical device process development.
• Proven experience in manufacturing and project/program management.
• Solid understanding of ISO 13485 and FDA regulatory requirements.

Responsibilities

• Collaborate with teams to develop and improve manufacturing processes.
• Lead automation initiatives ensuring compliance with quality standards.
• Identify and drive implementation of process improvements.

Skills

Risk analysis

Problem-solving

Process validation

Lean principles

Statistical techniques

Education

Level 8 degree in Engineering or related discipline

Green Belt certification

Job description

A leading medical device company in Galway, Ireland, seeks a Senior Process Development Engineer. This role focuses on designing and validating manufacturing processes to ensure device safety and compliance. The ideal candidate has over 5 years of experience, a Level 8 engineering degree, and expertise in Lean principles and regulatory standards. Responsibilities include collaborating with production teams, leading automation initiatives, and driving process improvements. This position offers an opportunity to impact operational excellence in a dynamic industry.