Delivering on the promise of medical innovation begins at Boston Scientific.
By delivering innovative products that help clinicians improve the lives of patients every single day, Boston Scientific makes a profound impact on the quality of medical care around the world. As we continue to transform the field of medical technology, we seek dedicated individuals who possess the integrity and creative spirit needed to thrive in an innovative company. Join a global organization that is fueled by the diversity and talent of its entire workforce.
Principal Quality Engineer, Design Assurance
Description
As a fully qualified quality engineer for the Imaging Division, plan and conduct work to ensure that new product development, manufacturing, and post market surveillance processes conform to BSC requirements, applicable ISO/EN standards, as well as FDA QSR, European MDD, and other applicable regulatory requirements. Work is independently performed with general instructions as to the objectives expected; Provides technical guidance on unusual or complex problems and supervisory approval on proposed plans for projects
Specific Duties and Responsibilities
Participate with R&D and production as a core team Quality leader providing quality engineering support and leading extended teams in the development of new products, processes for the continuous improvement of medical device products and clinical workflow. Participate in the development and qualification activities related to platform and breakthrough products.
Contribute to the development of verification & validation plans, testing, and generation of test reports.
Lead in the development of the risk management process.
Participate in the compilation and review of technical documentation for both domestic and international regulatory submissions.
Assist project teams on compliance with design control requirements per FDA QSR, European MDD, ISO 13485 and other applicable ISO/EN standards.
Facilitate and perform internal QA audits.
Analyze reports and returned products and recommend corrective/preventive actions.
Perform statistical analysis to assess cost of, and determine the responsibility for products or materials that do not meet required standards and specifications.
Participate in MRB as appropriate.
Position Qualifications
Minimum education: BS degree in Engineering, plus directly related experience, MS. degree in Engineering is preferred; or the equivalent combination of education and experience required to perform at this level.
Minimum experience: 8+ years of quality assurance and reliability experience supporting product development and/or manufacturing. Working knowledge of GMP and ISO 13485 Quality System preferred; ASQ certification and experience in medical device capital equipment industry preferred. Experience in one or more of the following necessary: auditing, design review, sterilization, project/program management (product development team participation).
