19 days ago
Design Assurance Engineer
About Your New Employer
In your new job as Design Assurance Engineer, you will be working for a leading Medical Device company in Galway. In your new job you will be working towards saving people's lives.
About Your New Job
- You will act as reviewer for all design activities including design changes and assessment of all changes made by external manufacturers.
- It's your job to routinely provide design assurance guidance and direction to engineers and technicians.
- You will Maintain the Design History files, including managing the filing, storage and retrieval of Design Quality Records.
- As Design Assurance Engineer, you will work with product development to establish design specifications and product requirements
- You will ensure all product quality standards and specifications are defined and achieved in line with company and Regulatory requirements including MDD 93/42 EEC and FDA requirements.
- It's your job to lead risk management process and preparation of risk management files including Use and Design FMEAs as required.
- You will give input to the Product design teams in identifying the product testing required and in the development of the Design Verification and Validation plans, protocols and reports including specifically advising on sample sizing (as an output of the dFMEA).
- You will work with PD and reg to Prepare Standard Checklists for all the applicable main harmonized standards and ensure compliance to these standards
- You will be responsible for generation and review of quality and technical documentation / change requests to support design activities.
- You will provide oversight on the development of new test methods
- Your job is to oversee the Product Sterilization cycle development
- You will act as SME for Biocompatibility
What You Need
- A Bachelor (level 8) of Engineering, Sciences or equivalent experience
- 4 years experience within Medical Device industry working in Design Assurance
- Knowledge and demonstrated practice of risk management methodologies as per EN ISO14971.
- Previous experience in Ethylene Oxide sterilization, biocompatibility & transportation testing an advantage.
What's on Offer
In addition to all statutory entitlements and a meaningful job where you help save lives, you will get:
- Annual Bonus
- Fully covered Health Insurance
- Hybrid - 2 Days WFH
- Pension Scheme
- Stock Ownership Programme
- Career Progression Opportunities - Looking for someone who is ready for quick promotion
Apply for your new job now by clicking the apply button, or contact Dean Flynn at Sigmar Recruitment for more information T: +353 91 455306 E: firstname.lastname@example.org
All applications will be treated with the strictest of confidence. Sigmar will never forward your CV to a third party without prior consent
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