Connecting to LinkedIn...

Vacancy Details


107586 - Design Assurance Engineer - Galway

Contract Type: Permanent
Location: Galway
Date: 7/04/2020
Job Reference: 107586
Contact Name: Amanda Reynolds
Contact Email:

Job Description

Design Assurance Engineer - Galway - 107586
Design Assurance Engineer

Our client a medical device company in Galway are currently looking to recruit a Design Assurance Engineer for their site. You will provide input to the companies’ development teams in the design of highly complex medical devices. You will ensure that compliance to customer and regulatory requirements is demonstrated and help to ensure successful transfer of the design to manufacturing. You will be responsible for accurate, independent evaluation of Design History File documentation and overall Quality System compliance

• Plans, conducts and executes design assurance activities requiring judgment in the independent evaluation, selection and the substantial adaptation of standard mechanical engineering techniques, testing procedures and criteria
• Works closely with product development engineering and the client team to establish the system design specifications and product requirements
• Works closely with design, development, quality, regulatory, and the client team to establish and document the master verification plan in conformance with the system design specification and sound testing principles
• Performs and documents all engineering studies and reports to satisfy the master verification plan
• Plans, coordinates and executes design verification testing to directly support the master verification plan
• Participates with the engineering team to establish and review the design FMEA
• Routinely provides design assurance guidance and direction to engineers and/or technicians for the duration of a project assignment
• Possesses a comprehensive understanding of the application of product specific standards such as ISO 10555 principles, design FMEA practices, and any industry standards to ensure products satisfy all ISO 13485 requirements
• Support various QA/RA activities including quality management, system reviews, internal and external regulatory agency audits, etc
• Leads risk management (ISO 14971) activities for the project, including Usability Engineering requirements in compliance with IEC 62366-1 and associated guidance documents
• Leads Biocompatibility activities for the project as required, in compliance with ISO 10993 series of standards
• Evaluation of new products, assuring the safety and efficacy of the devices
• Design verification and shelf life protocols / reports review and approval
• Lead and own CAPAs as required, drive Root cause investigations; drive problem solving efforts for quality issues
• Clearly present information to Regulatory Affairs to minimize Regulatory Agency questions
• Support customer complaint analysis and post market surveillance activities
• Generate and approve change requests

• You must have a minimum of 2 years of relevant experience with a Bachelors degree or higher in Engineering, or a related discipline
• Must be able to work independently and as a member of a cross-functional team, to multi-task and do what it takes to meet high expectations and tight deadlines. Will be working on highly visible projects in high-pressure situations
• Must have good written & oral communication skills and the ability to communicate appropriately with different engineering teams, Product Management, vendors and partners, and customers
• Must be able to travel occasionally to meet with customers / project teams

For further information on this Design Assurance role in Galway please contact Amanda Reynolds on 0860468858/

Check out all our open jobs on our HERO Recruitment website –

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Share this Job

“I have worked with HERO recruitment (formerly HERO recruitment) for a number of years both within my current and previous position. I have always found HERO recruitment excellent to partner with, the consultants know our industry and cultural fit and can therefore successfully source high calibre candidates to match our open vacancies. I find HERO recruitment very professional to deal with and any candidates I interview who are sourced by HERO always have a positive recruitment experience”.

Moira Faherty,
Human Resources Manager
Chanelle Group

“My very first impression was that I was dealing with a recruitment company who were extremely professional, supportive and knowledgeable of the role for which I was applying. Not only were the responsibilities of the role explained to me in great detail, but they also went to great lengths to really understand the depth of my technical, managerial and leadership experience and capabilities. What impressed me the most was their personal touch in building a strong relationship with me as a candidate and in maintaining regular contact with me on the status of the role throughout the application process”.

Adrian Rice,
Engineering Manager 
Boston Scientific

“HERO have been a key strategic recruiting partner to Hollister ULC over many years. During our continued growth and expansion at our facility in Ballina, Hero have worked closely with us to really understand our recruiting needs, the calibre of talent we are looking for, and the fit for our Hollister culture. HERO have successfully sourced and placed candidates for us into Research and Development, Project / Process Engineering, Supply Chain and key Management roles.  They have a very experienced and professional team, and bring an excellent regional, national and international perspective”. 

Tom Horkan,
Asst. HR Manger
Hollister ULC, Ballina, Co. Mayo

"From the first prompt call-back to the ultimate congratulatory call to inform me of a job offer, Karl was an absolute professional; sound advice, solid research and knowledge of companies, unwavering persistence and friendly encouragement. West is best, so for anyone looking for a technical role, talk to Karl"

Fiachra Collins
Computer Vision Algorithm Team Manager

“HERO Recruitment continues to be a valued partner in supplying high calibre candidates to all three Boston Scientific sites in Ireland. In particular they have been successful in delivering on specific roles for key project scale-ups. HERO has also provided on-site recruitment presence during increased activity when required and consistently operate in a highly professional and competent manner”.   

Lorraine McDonnell,
Senior Talent Acquisition Specialist
Boston Scientific 

“HERO Recruitment were instrumental in sourcing and delivering key talent to the organisation and enabled us to meet our key deliverables within our start-up phase. They thoroughly understood our culture and constantly over delivered on our expectations. Our partnership with HERO Recruitment has without a doubt been  a professional and collaborative one. HERO exceed themselves in all aspects of recruitment and are an absolute pleasure to work with”.

Christine Power,
VP of Human Resources

“HERO recruitment is an extension to our talent acquisition team. From hiring strategy meeting to the induction of the right talent, the HERO recruitment team provide an exemplary service. They are knowledgeable about our business needs, responsive and thorough. A true talent acquisition partner”. 

Orla Keady-Giblin,
Human Resources Manager
Ingersoll Rand – Thermo King

I am extremely grateful to Anne-Marie at HERO Recruitment for helping me land an opportunity in Ireland. She had a great deal of information regarding the job profile, was extremely prompt in arranging an interview and followed it up brilliantly. She was an excellent point of contact between the employer and me during the whole process. She has good knowledge about the process and was well aware of the timelines. I would recommend Anne-Marie, HERO Recruitment to anyone who is looking for opportunities in the country

Nikhil Pradeepkumar
Optical Engineer
Valeo Vision Systems

Clients we are proud to work with