R&D Engineer II - Medical Devices Quality & Compliance

Sigmar Recruitment; Galway; On-site; EUR 55,000 - 75,000; Full time

Benefits offered by this job

12‑month contract

Strong path to permanency

Job summary

Sigmar Recruitment is seeking an R&D Engineer II for a 12-month contract in Galway. The role focuses on advancing a high-profile medical device project with emphasis on patient safety, product quality, and regulatory compliance.

You will assess product designs, identify design gaps, and implement risk-based remediation while collaborating with cross-functional teams to ensure robust documentation for compliance activities.

Qualifications

• Minimum 3+ years’ experience in Medical Device R&D, or 3+ years’ combined R&D and Design Assurance.
• Experience with design controls, verification and validation activities.
• Knowledge of risk management and hazard analysis in medical devices.
• Familiarity with FDA/QMSR and ISO 13485 quality systems.
• Strong documentation and stakeholder management skills.

Responsibilities

• Participate in 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 existing and in-development products.
• Collaborate cross-functionally to drive quality improvements.
• Prepare high-quality documentation to support compliance activities.

Skills

Medical Device R&D

Design Controls

Risk Management

Regulatory Compliance

Documentation

Cross-functional Collaboration

Quality Systems

Education

NFQ Level 8 Bachelor's Degree in Engineering, Science or equivalent

Job description

Sigmar Recruitment is seeking an R&D Engineer II for a 12-month contract in Galway. The role focuses on advancing a high-profile medical device project with emphasis on patient safety, product quality, and regulatory compliance.

You will assess product designs, identify design gaps, and implement risk-based remediation while collaborating with cross-functional teams to ensure robust documentation for compliance activities.