Jobs and Careers

Senior Design Assurance Engineer

Irelandfull_timeVerifiedPosted 23 Jul 2024

About the role

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 Senior Design Assurance Engineer on a permanent basis to join us on our mission. Job Purpose Fulfil the quality assurance responsibilities of BSC’s product development and related sustaining engineering activities, including: <ul> <li>Creating and maintaining a culture of commitment to improving patient safety, customer satisfaction and product quality in BSC.</li> <li>Assuring compliance by interpreting and fulfilling regulatory requirements applicable to the medical device industry.</li> <li>Promoting and effecting compliance to BSC’s quality, business and health & safety systems and market/legal regulations.</li> <li>Analysing, reducing and managing risks associated with the design, use and manufacture of BSC devices.</li> <li>Selects appropriate techniques for problem solving and makes solid and consistent Engineering and Quality recommendations.</li> <li>Providing expertise in BSC’s product development systems to project teams</li> <li>Supervising, leading and coaching members of the design assurance department</li> </ul> Key Responsibilities General <ul> <li>Interfaces with R&D, Regulatory Affairs, Clinical, Marketing, Process Development and Manufacturing functions in a project team environment.</li> <li>Liaise with corporate and divisional quality systems and regulatory affairs personnel in ensuring compliance of product development activities to internal and external requirements.</li> <li>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.</li> <li>Continually seeks to drive improvements in product and process quality.</li> <li>Implement, maintain and update procedures that ensure that R&D documentation constantly meets BSC’s Product Development Process and Design Control requirements.</li> <li>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.</li> <li>Support internal and external audits.</li> </ul> Technical <ul> <li>Provides regulatory compliance, risk management, design control and quality systems expertise to the team.</li> <li>Identifies and resolves complex exceptions to work assignments.</li> <li>Summarises, analyses, draws conclusions and makes appropriate decisions from test results or other process related findings.</li> <li>Fully conversant with verification/validation techniques, risk management, statistical techniques and associated regulatory requirements</li> <li>Build Quality into all aspects of work by maintaining compliance to all quality requirements.</li> <li><s