Senior Design Assurance Engineer - Medical Devices

The Senior Design Assurance Engineer will be responsible for providing QA technical and compliance expertise as part of cross functional product development teams tasked with establishing customer needs, developing new products, remediation and/or modifying existing designs.

The ideal candidate is someone who can complete work assignments under limited supervision/guidance, thrives under pressure and is committed to an exceptional level of delivery standards.

You will join a dedicated QA/RA team within a newly established Life Sciences Practice in Expleo Ireland, supporting projects with our clients and helping to grow the team.

This is a fantastic opportunity for a Design assurance professional who will be an integral part of the Life Sciences Team at Expleo Ireland, which will allow for personnel learning and development opportunities through engagement with client projects.

• Apply knowledge of design control and risk management principles and quality engineering techniques throughout the product development process
• Contributes to Design Verification and Validation Strategies with functional partners (R & D and Regulatory Affairs) to assure an efficient regulatory submission approval path
• Good working knowledge of test strategies for Bio-compatibility, Sterilization, Shelf-life Protocols and Reports, Packaging Validation to applicable standards and ability to review and provide input to these areas of the product development process
• Perform Gap Analysis as required of technical documentation for EU MDR 2017/745 and other projects as required
• Understand and apply Risk Management concepts used to ensure Product Safety requirements in accordance with EN ISO 14971:2019+AMD11:2021 (ISO 14971:2019) and related guidance per ISO/TR 24971:2020
• Generation of risk management file documents; Risk Management Plan, Hazard Analysis, Design FMEA, Process FMEA, Risk Management Report  
• Good working knowledge of test strategies for compliance to product related standards such as ISO 10555-1, ISO 11070 and ability to review and provide input to Design verification Protocols and Reports
• Manage and maintain the records related to design control and risk management activities in accordance with QMS requirements at the client site
• Ability to interpret polices, regulatory and/or governmental regulations, and internal regulations to assure compliance to design control, risk management and Quality Management System elements
• Ability to apply systematic problem-solving methodologies in identifying, prioritizing, presenting, and resolving quality issues
• Methodical review approach and is capable of initiating and leading change and continuous improvement
• Proactive and stays abreast of industry best practices with respect to regulatory requirements for medical devices, knowledge of the application of EU MDR 2017/745
• Perform all activities in compliance with client safety standards and SOPs
• Participate in other projects/duties as assigned

• Third level qualification in Engineering or Science. Minimum Bachelor’s Degree (Level 8) in a Science / Technology / Engineering related discipline. Masters (Level 9) in a related Engineering or Science discipline advantageous.

• Excellent client-facing skills
• Proven track record of applying Design control and Risk management requirements as part of Product Development Processes resulting in successful product launches and ability to interact and respond to regulatory agency (Notified Bodies, FDA) questions as required
• People management skills - introducing and building ways in which people can learn from each other, encouraging mentoring and the transfer of knowledge by designing and delivering learning interventions
• Team work and emotional intelligence. Ability to work collaboratively in team environments
• Good self-management – continuous performance is both an objective and a mind-set
• Has an innovative approach – a bold thinker and doer, matching creativity with vigilance
• High value on openness and transparency
• Strong interpersonal and communications skills, and fluent in English, both in writing and speaking. Ability to communicate quality/regulatory concepts effectively.
• Thinks Critically and makes sound decisions is a must

• Minimum 5 years’ experience in a Medical Devices environment with proven track record of collaborating with others to design and develop high priority medical technologies and successful regulatory submissions approvals
• Working knowledge of and experience with U.S FDA regulations, the Medical Devices Directive (93/42/EEC), EU MDR 2017/745, ISO 13485 Quality System Standard, ISO 14971 Risk Management, IEC 62366 Usability Engineering (Human Factors Engineering)
• Knowledge of medical devices therapeutic areas (E.g., Coronary, Structural Heart, Vascular and Neurovascular).

• Collaborative working environment – we stand shoulder to shoulder with our clients and ours peers through good times and challenges
• We empower all passionate technology loving professionals by allowing them to expand their skills and take part in inspiring projects
• Expleo Academy - enables you to acquire and develop the right skills by delivering a suite of accredited training courses
• Competitive company benefits such as medical and dental insurance, pension, life assurance, employee wellbeing programme, sports and social events, birthday hampers and much more!
• Always working as one team, our people are not afraid to think big and challenge the status quo.

''We are an equal opportunities employer, which means that we are committed to providing equality of opportunity in employment to all persons.''

“At Expleo, we understand that many people experience imposter syndrome throughout their lifetime, please do not let this discourage you from applying for this role. Our Talent Acquisition Team welcomes all CV’s and will consider your application in line with the values, requirements and role competencies.”

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