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 13485.
Benefits
* Competitive and attractive employee compensation package
* Pension contributions
* Health insurance
* Paid public holidays
Location: Galway, Ireland | onsite
Desired Skills and Experience
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)
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 13485.