Design Assurance Engineer

Hero Recruitment; Galway; On-site; EUR 55,000 - 83,000; Full time

Job summary

Hero Recruitment seeks a Design Assurance Engineer for a 12-month contract in Galway, with onsite preference for 4 days a week. The role supports a major acquisition and integration programme within the renal denervation portfolio, focusing on design controls, risk management and DHF documentation.

Ideal candidates will have a degree in engineering and experience in medical devices, Class II/III devices, CAPA, and cross-functional collaboration across R&D, Manufacturing and Regulatory Affairs.

Qualifications

• Degree in Mechanical, Biomedical, Electronic or related Engineering discipline.
• Experience in Design Assurance or Quality Engineering within medical devices.
• Strong knowledge of Design Controls and Risk Management.
• Experience with Class II or Class III medical devices.
• Familiarity with Change Control, CAPA and DHF documentation.

Responsibilities

• Provide Design Assurance support across an acquisition and product integration programme.
• Ensure Design Controls and Risk Management throughout product development lifecycle.
• Participate in risk management activities including risk assessments, FMEAs and risk documentation.
• Support design changes, engineering change control and Design History File (DHF) documentation.
• Collaborate with cross-functional teams including R&D, Manufacturing, Regulatory Affairs and Quality.
• Drive quality activities including CAPA, non-conformance investigations and continuous improvement initiatives.
• Ensure products meet internal quality standards and applicable regulatory requirements.

Skills

Design Assurance

Quality Engineering

Product Development

Cross-functional teamwork

Education

Degree in Mechanical/Biomedical/Electronic Engineering

Job description

Design Assurance Engineer

12-Month Contract | Galway (4 Days Onsite Preferred)

About the Role

We are partnering with a leading global medical device company to recruit a Design Assurance Engineer for a high-profile 12-month contract. This role will support a major acquisition and integration programme within the rapidly growing renal denervation portfolio, contributing to the development and integration of innovative Class II/III medical technologies.

The level is flexible and can accommodate candidates with strong Design Assurance experience or those with relevant Quality or Product Development backgrounds looking to move into a design-focused role.

Key Responsibilities

• Provide Design Assurance support across an acquisition and product integration programme.
• Ensure compliance with design control requirements throughout the product development lifecycle.
• Participate in risk management activities including risk assessments, FMEAs and risk documentation.
• Support design changes, engineering change control and Design History File (DHF) documentation.
• Collaborate with cross-functional teams including R&D, Manufacturing, Regulatory Affairs and Quality.
• Drive quality activities including CAPA, non-conformance investigations and continuous improvement initiatives.
• Ensure products meet internal quality standards and applicable regulatory requirements.

What We're Looking For

Essential

• Degree in Mechanical, Biomedical, Electronic or related Engineering discipline.
• Previous experience in Design Assurance, or relevant experience in Quality Engineering or Product Development within medical devices.
• Strong understanding of Design Controls and Risk Management.
• Experience working with Class II or Class III medical devices.
• Knowledge of core quality systems including Change Control, CAPA and compliance processes.
• Ability to work effectively within cross-functional engineering teams.

Desirable

• Experience with medical electrical systems.
• Previous experience with Boston Scientific or another large multinational medical device company.
• Familiarity with acquisition, integration or new product development projects.

Contract Details

• 12-month hourly rate contract
• Galway | 4 days onsite preferred
Renal Denervation | Acquisition & Integration Programme