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 I on a permanent basis to join us on our mission.
Job Purpose Demonstrates commitment to the Quality Policy (patient safety and product quality) through their daily execution of sound quality practices and the maintenance of an effective quality system. Support the application of Design Controls and Regulations in Sustaining Engineering and Product Development ensuring that we continue to deliver products of the highest safety and quality to our patients.
Key Responsibilities Familiarity with requirements and procedures that govern medical device production and Design Control.Understanding of Design Assurance requirements to support marketed product, product development, design changes and technology transfers and to ensure activities comply with all internal and regulatory requirements.Interfaces with Operations teams, R&D, Regulatory Affairs, Clinical, Medical Safety, Complaints Management Centres and Post Market Quality Assurance team environment providing quality and technical input.Provides design quality support and product assembly knowledge in the resolution of PIRs, complaints investigation, CAPAs, non-conforming product, VIPs and regulatory requirement changes.Supporting BSC's transition to EU MDR by collaborating with submissions, reviewing notified body feedback, assisting divisional product teams with submission responses, and acting on feedback trends by driving process improvement projects across the design controls sub-processes.Provide detailed assessments of impacts for design and process changes on commercialized products.Acts as an inclusive team member in drawing conclusions and makes appropriate decisions from test data using excellent analytical and problem-solving abilities.Support internal and external audits and audit responses for commercialized and new products.Collaborate in development and execution of Design Verification plans, protocols and reports for new and commercialized products as a member of multi-functional team activities through the life cycle of the product from concept, development, commercialization and end of life phases.Assure quality and completeness of documentation associated with design verification studies (including test data, manufacturing records, investigations and deviations) and generate submission packages in conjunction with Project Teams and Regulatory Affairs for regulatory submissions.Coordinate and contribute with test laboratories and teams for product investigations, OOS, OOT and protocol deviations.Ensure and maintain regulatory compliance with appropriate guidance documents, - company SOP/WIs, cGMPs, EU/FDA/Global and ICH guidelines for design verification activities.Uses knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality.Is a good team member, fully motivated to achieve and demonstrate best practices in line with the department and site objectives and continually seeks to drive improvements in product and process quality.Education & Experience NFQ Level 8 qualification (240 credits) in a STEM discipline (Science, Engineering).Minimum of 2+ years' experience in a Design Assurance capacity.Good technical capabilities, communication skills, teamwork abilities and initiative.Proven ability to work well both as part of a team but also able to work on own with minimum supervision.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.
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