Design Assurance Engineer
2 weeks ago
Direct message the job poster from Force Recruitment
Engineering & Science Recruitment Consultant | Force Recruitment | Assoc CIPD |Design Assurance Engineer II
Location - Galway
2 Positions - 1 Permanent, 1 maternity contract
Force Recruitment have currently partnered with one of the top medical device manufacturing clients who are on the lookout for 2 Design Assurance Engineers II for their site in Galway.
The individual in this position is responsible for leading and collaborating with cross-functional teams, including R&D, Regulatory Affairs, Process Development, Clinical Affairs, and Manufacturing Engineering.
Responsibilities:
- Interfaces with R&D, Regulatory Affairs, Clinical Marketing, Process Development, and Manufacturing in a project team environment providing Technical and Quality expertise to the team.
- Provides both quality and technical input to the stage gate design reviews, risk management, design verification/validation protocols and reports, for new development projects as well as design/process changes to existing products.
- Review/analyze whether current products and processes comply with standards such as ISO 13485 & EU MDR etc.
- Have experience in risk management, validation techniques, statistical techniques, and compliance with FDA/MDR regulatory requirements. Responsible for the compilation of design verification/validation protocols, reports and design/quality documentation supporting product development/sustaining engineering projects.
- Uses opportunities in project assignments to develop self & other team members. Gives technical guidance to Design Assurance Engineer I, Graduate Design Assurance Engineer, and Design Assurance Technician.
- Build Quality into all aspects by maintaining compliance for all quality requirements. Participates in external audits including notified body.
- Provides design quality support in the resolution of product assessments, complaints investigation, CAPAs, regulatory requirement changes.
- Methodical review approach and capable of initiating and leading change through continuous improvement.
Education and Experience:
- A degree in Engineering, Technology, or Science.
- At least 3-5+ years' experience working in a regulated medical device or pharmaceutical company.
- Excellent planning and coordination skills.
- Excellent verbal and written communication skills.
- Excellent attention to detail skills.
- Training in product risk management, problem-solving methods, reliability engineering, process validation, software validation, usability or biocompatibility would be advantageous.
Skills and Competencies:
- Excellent understanding of ISO 14971 & 13485.
- Ability to work within a team environment to achieve agreed company goals.
- Ability to communicate quality/regulatory concepts effectively.
- Excellent understanding of ISO 13485 and FDA QS regulations.
- Understanding of Quality Systems.
- Understanding of Design Control Process.
- Proficiency in the use of desktop software applications such as MS Office, Word, Excel, PowerPoint.
- Some travel may be required with the role.
Associate
Employment typeFull-time
Job functionEngineering, Design, and Manufacturing
IndustriesMedical Equipment Manufacturing, Pharmaceutical Manufacturing, and Manufacturing
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