Design Assurance Engineer

About Your New Employer

• Join a growing start-up medical 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.