Are you a manufacturing engineer looking to progress your career?
Are you interested in taking the next step in your professional journey with a global leader in the medical device industry?
Are you ready to challenge yourself in a fast-paced and high-regulated environment?
You could be the perfect candidate for this opportunity
Don't hesitate, apply today
Job Description
Our client in Galway require an experienced Manufacturing Engineer with a background in electronics engineering to support an upcoming project.
This role will focus on manufacturing process development for New Product Introduction.
You will be based onsite and work directly with manufacturing process owners.
Key Responsibilities
Individuals more than 2 years med device experience in Manufacturing, Quality, or new product introduction (e.g. process development) role
Familiar with Manufacturing Documents (e.g. SOP's, change control, process risk (e.g. PFMEA) and validation (IQ, OQ & PQ) documents
Writing/approving validation protocols and Process Characterisation reports (where required)
Writing/Reviewing and approving Repeat Action Assessments (RAA) and Acceptance Equipment List (AEL's)
Reviewing, updating, and approving Manufacturing Instruction (SGOI's) and MES documents
Owner of DMR remediation NCEP/CAPA's ( if they occur)
Key Requirements
Engineering degree with 2-3 years' relevant industry experience; preference for medical device
Background in process development for NPI's
Strong technical writing and documentation skills.
Knowledge of 21 CFR Part 820, ISO *****.
Benefits
Competitive and attractive employee compensation package
Pension contributions
Health insurance
Paid public holidays
Location
Galway, Ireland | onsite
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