Design Assurance Engineer
About Your New Employer
* Join a growing start-upmedical device company based in Galway.
* Be part of a company committed to equal opportunity and cutting-edge medical advancements.
About Your New Job
* Lead the Design Review process: Ensure compliance with internal procedures and EU/FDA requirements.
* Maintain Design History files: Manage filing, storage, and retrieval of Design Quality Records.
* Collaborate with product development: Establish design specifications and product requirements.
* Ensure product quality standards: Achieve standards in line with company and regulatory requirements, including MDR and FDA.
* Lead risk management process: Prepare risk management files, including Use and Design FMEAs.
* Identify product testing requirements: Write design verification and validation plans, protocols, and reports.
* Liaise with external suppliers: Coordinate product testing and support R&D with component suppliers.
* Generate and review documentation: Support design activities with quality and technical documentation.
* Provide design assurance guidance: Offer direction to engineers and technicians.
* Assist with regulatory submissions: Compile design dossiers, technical files, and regulatory documentation.
* Support QA activities: Implement ISO 13485, conduct system reviews, and perform internal/vendor audits.
* Maintain cleanroom processes: Ensure design to process risk management linkage.
What Skills You Need
* Qualification in quality or STEM discipline.
* Minimum 3 years’ experience in quality engineering, preferably in design assurance.
* Experience in risk management and usability creation.
* Proficiency in Design Verification/Validation testing.
* Familiarity with quality assurance software tools and processes.
* Strong communication and interpersonal skills.
* Excellent analytical and problem-solving abilities.
* Ability to work effectively in team environments.
* Capability to provide design assurance guidance and training to team members.
What’s on Offer
* Competitive salary and benefits package.
* Opportunities for professional growth and development.
* Collaborative and innovative work environment.
* Occasional travel opportunities.
What’s Next
Apply now by submitting your resume to eward@sigmar.ie. If the job isn’t quite right but you are looking for something similar, please get in touch. We also have multiple Temp, FTC, and Contract jobs available.
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