close

Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

crome
Google Chrome
IE
Internet Explorer
firefox
Mozilla Firefox
opera
Opera

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Apply for this job

Name:

Surname:

Email:

Phone:

Cv:

Salary Expectations:

Education:

Experience:

Current Location:

Notice Period:

Write here your cover note:


If you would like us to create a jobseeker account for you, giving you access to
account management, job alerts and one-click applications, then please tick this box

If you are having difficulty you can always email your cv to applications@lifescience.ie
Details

Design Assurance Engineer


Reference:JCAOLJ-244026 Location: Galway
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Design Engineer

Overview:
The company is a fast growing and dynamic organisation and the company reserves the right to change the job description, role, and reporting structure to meet the evolving needs of the business.
You must be able to travel domestically and internationally by air and car, and work / travel occasional weekends.
As the Design Assurance Engineer you are expected to develop and evolve your skills to stay abreast of pertinent changes to all relevant standards and regulations.

Position Summary:
You will report to the VP of Quality and Regulatory Affairs. As the Design Assurance Engineer you will work as part of the Quality and Regulatory Affairs teams and be responsible for tasks that are related to the development and maintenance of the design assurance activities to support product development projects.

Your Responsibilities:

  • Support the VP of Quality and Regulatory Affairs in the development and maintenance of a quality system in compliance with ISO 13485:2016 and the quality system regulation 21CFR Part820.
  • Represent the quality function at R&D team meetings and support the R&D team in meeting their objectives by providing advice and completing documentation reviews in a timely manner.
  • Support design assurance activities within the organisation preparing protocols, organising and supporting testing and preparing comprehensive test reports to support regulatory filings.
  • Participate in the risk management process to ensure that all risks are captured in the risk management report and ensure that all risks are mitigated in accordance with the requirements of ISO 14971:2012.
  • Lead biocompatibility activities for the project as required, in compliance with ISO 10993 standards.
  • Oversee and manage testing completed by external test houses on behalf of the company ensuring compliance with test protocols and all regulatory standards.
  • Prepare reports, documents, procedures, specifications, and other such technical documents as required in a clear manner to ensure the success of the project.
  • Lead and own CAPA as designated, drive root cause investigations and corrective actions for design assurance issues.
  • Support the quality and regulatory affairs department in quality management system reviews and in internal and external regulatory agency audits.
  • Prepare quality system metrics on a pre-determined basis to support management meetings and for management review.
  • Support the continuous improvement of quality system processes and the business generally.
  • Complete tasks as designated by your supervisor to support the needs of the business.

What you need:

  • Bachelor’s degree in Science or Engineering is a pre-requisite for this role.
  • At least two years experience in a quality engineering or regulatory role ideally in a regulated environment.
  • Design assurance experience in the medical device industry is an advantage.
  • Requires excellent written, interpersonal communication and presentation skills and an ability to effectively present information to peers.
  • Excellent communications skills: Can understand with ease virtually everything heard or read. You can summarize information from different spoken and written sources, reconstructing arguments and accounts in a coherent presentation.
  • You hold yourself and others accountable to meet commitments by following through, acting with a clear sense of ownership, and taking personal responsibility for decisions, actions and failures.
  • Able to prioritize and focus on the few critical objectives amongst numerous project tasks and activities.
  • You must possess a valid driver’s license and passport.

What you have:

  • Contributes to the success of the company’s products.
  • You are a self-starter who can see and deliver the work required to advance the company goals with a minimal amount of direction.
  • Reliable expertise on all matters pertaining to the design assurance function.
  • You have a solid grasp of team dynamics and can participate in teams that deliver outstanding results.
  • Brings support and positive attributes to a culture that is respectful, supportive, goal oriented, scientific, and diverse.
  • Supports colleagues in the achievement of their strategic objectives.
  • Is a positive role model to employees across the group.