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:
1. 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.
2. 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.
3. Review/analyze whether current products and processes comply with standards such as ISO 13485 & EU MDR etc.
4. 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.
5. 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.
6. Build Quality into all aspects by maintaining compliance for all quality requirements. Participates in external audits including notified body.
7. Provides design quality support in the resolution of product assessments, complaints investigation, CAPAs, regulatory requirement changes.
8. Methodical review approach and capable of initiating and leading change through continuous improvement.
Education and Experience:
1. A degree in Engineering, Technology, or Science.
2. At least 3-5+ years’ experience working in a regulated medical device or pharmaceutical company.
3. Excellent planning and coordination skills.
4. Excellent verbal and written communication skills.
5. Excellent attention to detail skills.
6. Training in product risk management, problem-solving methods, reliability engineering, process validation, software validation, usability or biocompatibility would be advantageous.
Skills and Competencies:
1. Excellent understanding of ISO 14971 & 13485.
2. Ability to work within a team environment to achieve agreed company goals.
3. Ability to communicate quality/regulatory concepts effectively.
4. Excellent understanding of ISO 13485 and FDA QS regulations.
5. Understanding of Quality Systems.
6. Understanding of Design Control Process.
7. Proficiency in the use of desktop software applications such as MS Office, Word, Excel, PowerPoint.
8. Some travel may be required with the role.
Seniority level
Associate
Employment type
Full-time
Job function
Engineering, Design, and Manufacturing
Industries
Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Manufacturing
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