Senior NPI Process Development Engineer | Galway
About the Role:
We're seeking a
Senior NPI Process Development Engineer
to join a leading MedTech organisation in Galway. This role will focus on developing and delivering complex device projects, from initial concept through commercialization, working closely with product development teams and suppliers.
Key Responsibilities:
* Collaborate with cross-functional teams to develop robust designs and manufacturable processes.
* Evaluate components, raw materials, and suppliers for quality, technical, and manufacturing capabilities.
* Drive process improvements, prototype builds, and validation strategies.
* Ensure compliance with regulated environments and internal change management processes.
* Identify project risks and develop mitigation strategies to maintain timelines and quality.
* Support supplier performance, technical issues, and inspection method development.
Requirements:
* Degree in Mechanical, Biomedical, or related Engineering field.
* 5–7+ years' experience in medical device process engineering or development within regulated environments.
Desirable Experience:
* Catheter or device process design/manufacturing experience.
* Knowledge of product lifecycle, validation, FMEAs, and protocol/report preparation.
* Experience with structured problem-solving (e.g., Six Sigma/DMAIC).
* Project management experience, including scheduling, resourcing, and deliverables.
What's on Offer:
* Highly competitive daily/hourly rate, based on experience.
* Opportunity to work on challenging projects in a hands-on, supportive environment.