Design Assurance Engineer II

Our Mission:

At Boston Scientific Galway, we are dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world.

We work collaboratively to solve healthcare’s toughest problems by developing solutions that matter most to those suffering from debilitating and life-threatening conditions and to the healthcare professionals who provide their care. 

We are seeking a Design Assurance Engineer II on a permanent basis to join us on our mission.

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

Key Responsibilities:

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 

At Boston Scientific, we recognise that nurturing a diverse and inclusive workplace helps us be more innovative. It is essential in advancing science for life and improving patient health. We stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer. Boston Scientific is committed to providing reasonable accommodations for applicants and employees with a disability. Should you require a reasonable accommodation during the recruitment process, please let us know.