Are you an electronics and 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, Electronics, 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
Key Responsibilities
* Contribute to electronics manufacturing tasks for product transfer through to production
* Analyze technical requirements and recommend appropriate components and design approaches
* Ensure designs meet product specifications and applicable regulatory standards
* Provide technical support to cross-functional product development teams
* Prototype, debug, and perform failure analysis on circuits and PCB assemblies (PCBA)
* Maintain compliance with quality systems and patient safety standards (e.g., ISO
Key Requirements
* Minimum of Bachelor's degree in Electrical Engineering, Electronics Engineering, or a related field
* 5+ years of relevant engineering experience in manufacturing environment
* Experience in medical devices or other regulated industries (e.g., defense, aviation) preferred
* Experience with analog and digital circuit design
* Proficiency in schematic capture and PCB layout tools
* Experience prototyping and debugging electronic systems
* Hands-on experience with drive and control electronics for motors may be required
* Familiarity with test automation
* Experience with international standards such as IEC and IEC 61000 is highly advantageous
* Strong analytical and problem-solving abilities