R&D Engineer II
About Your New Employer
- Contributing to a new, a high-profile, company-wide project.
- Dynamic environment focused on patient safety, product quality, and regulatory compliance.
- Opportunity to work alongside expert teams addressing products across their lifecycle—both legacy and in-development.
- This is a 12 month contract opportunity with strong progression for permanency.
About Your New Job
As an R&D Engineer, you will:
- Participate in comprehensive assessments of product designs and quality system processes.
- Identify compliance and design gaps to enhance patient safety and regulatory adherence.
- Execute risk-based remediation plans for both existing and in-development products.
- Collaborate cross-functionally to drive quality improvements.
- Prepare high-quality documentation to support compliance activities.
What Skills You Need
- Minimum 3+ years’ experience in Medical Device R&D, or 3+ years’ combined R&D and Design Assurance
- NFQ Level 8 Bachelor's Degree in Engineering, Science or equivalent.
- Demonstrated expertise in Design Controls (requirements, verification, validation)
- Strong background in Risk Management and hazard analysis
- Knowledge of Quality Systems (FDA/QMSR and ISO 13485)
- Experience in gap assessment, root cause analysis, and technical problem solving
- Excellent technical documentation skills
- Ability to collaborate with cross-functional teams and manage stakeholders
- Patient-focused, risk-based quality mindset
- Experience with remediating legacy products and technical files
- Familiarity with post-market surveillance and complaint trending
What's on Offer
- 12-month contract position
- Involvement in a high-impact, company-wide quality initiative
- Exposure to a diverse range of product development and quality remediation activities
- Work within a supportive, expert-driven environment
What's Next
Apply now or for more information, please contact us directly. If the role isn’t quite right but you’re interested in similar positions, please get in touch—we have multiple roles available.