Design Assurance Engineer II
On-site · Galway, Connacht, Ireland
Job Summary
Design Assurance Engineer II at Medtronic in Galway leads quality-focused product development activities within Interventional Cardiology Therapies, preparing test method validations, design verification, and shelf-life protocols while supporting risk management, regulatory compliance, and cross-functional collaboration to ensure high-quality medical device products. Key duties include preparing validation reports, maintaining design verification and shelf-life documentation, contributing to audits, and providing quality input into new product development and process improvements. The role requires a bachelor’s degree (or equivalent) and at least 2 years of relevant quality engineering experience in a highly regulated environment, with strong analytical and documentation skills and the ability to work with cross-functional teams.
Required Qualifications
- Bachelor’s degree in a relevant engineering or science field
- minimum of 2 years of relevant experience in Quality Engineering, Science, or a related field (master’s degree with zero years acceptable)
- Experience in a highly regulated industry, preferably medical devices
- Ability to work with cross functional groups to lead deliverables
- Experience of working in complaint handling/post market quality team
- Regulatory compliance knowledge (design verification, validation, risk management, change control)
- Strong documentation and test protocol skills
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