Boston Scientific Design Assurance Engineer II 

Ireland, Galway 

958366129

Job Purpose

Fulfil the quality assurance responsibilities of BSC’s product development and related PTP engineering activities, including:

• Creating and maintaining a culture of commitment to improving patient safety, customer satisfaction and product quality in BSC.
• Assuring compliance by interpreting and fulfilling regulatory requirements applicable to the medical device industry.
• Promoting and effecting compliance to BSC’s quality, business and health & safety systems and market/legal regulations.
• Analysing, reducing and managing risks associated with the design, use and manufacture of BSC devices.
• Selects appropriate techniques for problem solving and makes solid and consistent Engineering and Quality recommendations.
• Providing expertise in BSC’s product development systems to project teams

General

• Interfaces with R&D, Regulatory Affairs, Clinical, Marketing, Process Development and Manufacturing functions in a project team environment.
• Liaise with corporate and divisional quality systems and regulatory affairs personnel in ensuring compliance of product development activities to internal and external requirements.
• Monitor the release and updates of quality policies to ensure compliance with Product Development needs and communication of this information to the Product Development Group.
• Continually seeks to drive improvements in product and process quality.
• Implement, maintain and update procedures that ensure that R&D documentation constantly meets BSC’s Product Development Process and Design Control requirements.
• Provides the quality/independent review at defined design reviews, project design plans, risk management, design verification/validation protocols and reports, for new development projects as well as design/process changes to existing product lines.
• Support internal and external audits.

Technical

• Provides regulatory compliance, risk management, design control and quality systems expertise to the team.
• Summarises, analyses, draws conclusions and makes appropriate decisions from test results or other process related findings.
• Fully conversant with verification/validation techniques, risk management, statistical techniques and associated regulatory requirements
• Build Quality into all aspects of work by maintaining compliance to all quality requirements.
• Keeps up to date on all ISO/EN/FDA/MDD and other Product Development related regulatory requirements and relay this information to the Product Development group.
• Is a good team member, committed to the projects success and fully motivated to achieve and demonstrate best practices in line with the department and site objectives.
• Cardiac Valve Knowledge/Understanding:
  • Knowledge / understanding of EN ISO 5840-1 & -3
  • Material knowledge of nitinol
  • Material knowledge of animal origin (bovine or porcine)
  • Valve testing
• Familiar with Product Functional Testing including ageing studies
• Knowledge of the NCEP process

Education & Experience

• Level 8 Bachelors Degree (240 credits) in STEM (Quality, Science or relevant discipline)
• 3+ years experience in a similar role