Design Assurance Engineer

About the job

Are you interested in taking the next step in your career with a global leader in medical devices? Are you experienced in Design Control and Design Assurance? If so, and if you're ready to challenge yourself in a fast-paced environment, you could be the perfect candidate for this opportunity! Don't hesitate, apply today!

Job Description

Our client is seeking an experienced Design Assurance Engineer to join their team and form part of a preventive quality initiative. You will support a structured review of Design History Files (DHF) across selected key products. The position will focus on ensuring robust application of design controls, risk management, and test method validation.

Key Responsibilities

• Perform systematic reviews of Design History Files to identify missed activities or gaps
• Assess compliance of DHF content with internal procedures and global regulatory expectations
• Review core DHF records (User Needs and Design Inputs, Design Requirements, Hazard Analysis, DFMEA, or equivalent risk management files, Design Outputs, including Essential Design Outputs and associated evaluations)
• Evaluate verification strategies to confirm that approved TMVs are in place and align with global work instructions
• Identify gaps or deficiencies in test methods or TMV documentation and define remediation actions
• Confirm that design requirements are linked to appropriate risk controls
• Verify alignment between design requirements, design implementation, and risk management documentation.
• Support the definition and execution of remediation plans resulting from DHF review findings.
• Update or create design control documentation as required.

Key Requirements

• Strong experience working with design control frameworks
• Solid understanding of:
• Design controls and Design History Files
• Risk management (Hazard Analysis, DFMEA)
• Test Method Development and Test Method Validation
• Experience working in a regulated medical device environment.
• Strong attention to detail and ability to critically review technical documentation.
• Effective collaboration and communication skills across engineering and quality functions.

Benefits

• Competitive and attractive employee compensation package
• Pension contributions
• Health insurance
• Paid public holidays

Location: Ireland

Desired Skills and Experience Key Responsibilities

Perform systematic reviews of Design History Files to identify missed activities or gaps

Assess compliance of DHF content with internal procedures and global regulatory expectations

Review core DHF records (User Needs and Design Inputs, Design Requirements, Hazard Analysis, DFMEA, or equivalent risk management files, Design Outputs, including Essential Design Outputs and associated evaluations)

Evaluate verification strategies to confirm that approved TMVs are in place and align with global work instructions

Identify gaps or deficiencies in test methods or TMV documentation and define remediation actions

Confirm that design requirements are linked to appropriate risk controls

Verify alignment between design requirements, design implementation, and risk management documentation.

Support the definition and execution of remediation plans resulting from DHF review findings.

Update or create design control documentation as required.

Key Requirements

Strong experience working with design control frameworks

Solid understanding of:

Design controls and Design History Files

Risk management (Hazard Analysis, DFMEA)

Test Method Development and Test Method Validation

Experience working in a regulated medical device environment.

Strong attention to detail and ability to critically review technical documentation.

Effective collaboration and communication skills across engineering and quality functions.