Senior Manufacturing Engineer
Location:
Galway, Ireland
Department:
Manufacturing / Operations
Reports To:
Engineering Manager
Role Summary
The Senior Manufacturing Engineer provides technical leadership in developing, improving, and supporting manufacturing processes within a regulated medical device environment. This role focuses on process optimization, new product introductions, and ensuring compliance with quality and regulatory standards.
Key Responsibilities
* Develop, validate, and optimize manufacturing processes (IQ/OQ/PQ).
* Lead process improvements to increase yield, quality, and efficiency.
* Support new product introduction (NPI) from concept to production.
* Maintain compliance with ISO 13485, FDA, and GMP requirements.
* Lead root cause analysis and CAPA activities.
* Drive Lean and Six Sigma initiatives to reduce cost and waste.
* Provide technical mentorship to engineers and technicians.
* Specify, qualify, and maintain production and automation equipment.
Qualifications & Experience
* Bachelor's degree in
Mechanical, Manufacturing, Biomedical, or Industrial Engineering
(Master's preferred).
* 5+ years'
experience in a regulated manufacturing environment, ideally medical devices.
* Strong knowledge of
GMP, ISO 13485, and FDA 21 CFR Part 820
.
* Skilled in
validation, process development, DOE, and statistical analysis
.
* Experience with
Lean / Six Sigma
methodologies (certification an advantage).
* Excellent communication, teamwork, and project management skills.