Principal /Senior Design Assurance Engineer

Location

Remote | Canada

Job description

Our Client, a leading start up in Galway in looking for a  Principal /Senior Design Assurance Engineer  to join their team. The successful candidate will lead Quality Engineering support for all phases of the product development process including risk management activities within the product development cycle and working actively to mitigate product risks. The role will also require you to develop new test methods to ensure risks are analyzed and report on data gathered to support regulatory compliance.

Responsibilities include but are not limited to the following:

• Work collaboratively to drive patient-focused cancer care products from idea to manufacture by leading Design Assurance activities as part of an overall Product Development team, including: -
• Leading risk management activities, including developing risk management documentation to US FDA and EU MDR requirements and ensuring appropriate verification and validation testing against product risks ; 
  • Writing test method validations, design verification and shelf-life protocols, and test reports.
    
  • Creating design solutions to reduce product risks and ensure compliance with regulations and standards.
  • Work closely with R&D team members to communicate ISO standard and regulatory requirements, influencing design direction

• Take responsibility for the delivery of project goals in a timely fashion by working closely with, guiding, and building relationships with external suppliers and manufacturing partners, managing their time effectively and maintaining agreed timeline.​
• Be comfortable working cross-functionally between RA/QA and R&D, and have deep knowledge of ISO 13485 and IS0 14971
• Building regulatory strategies that efficiently bridge the gap between innovation and real patient impact.
• Implementing quality management processes that ensure an empowering experience for every patient
• Driving regulatory clearance so that patients can finally have access to the products that solve the needs that matter to them
• A passion to find creative solutions that ensure risks are addressed in a timely fashion, ensuring benchtop innovations are safely translated into real patient impact

• 5+ years of experience in R&D and/or Design Quality Assurance (preferably in a medical device environment).

• A primary degree in Engineering or Scientific, or equivalent experience.

• Experience with directly creating and managing Design History File documents such as Risk Management, Design Inputs, Test Method Design and Validation, and Design Verification Plans alongside experience writing formal testing protocols and test reports.

• A strong understanding of medical device regulatory requirements and applicable standards, in particular FDA guidance, ISO 13485, ISO 14971.
• Strong technical writing and communication skills
• A creative problem solver who is enthusiastic about new ideas and eager to bring innovative products to market as quickly as possible.
• A proactive team player. You seek to learn from colleagues and help develop your teammates.
• Resourceful, independent, and self-motivated with a hands-on attitude.
• Outstanding in written and verbal communication and collaboration skills. You are able to articulate ideas clearly and support ideas with evidence.
• Previous experience working with Class II electromechanical medical devices, Lead auditor training. and Experience working with IEC 60601 would be Advantageous

Note: By applying for this position, you may also be considered by Pale Blue Dot Recruitment for other or future related vacancies

Job tags

Salary