Principal Design QA Engineer

4 weeks ago

Marlborough, United States Boston Scientific Full time

Recruiter: Spencer Gregory HalePrincipal Design QA EngineerAbout this role:The Principal Design Quality Assurance Engineer is an experienced professional with wide-ranging experience and expertise in Sustaining quality engineering and New Product Development. The Principal Quality Engineer will develop, establish and maintain quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. This is a hybrid position based out of Marlborough, MA with the expectation to be in the office a minimum of two days per week. Your responsibilities include: Promotes Cross-Functional collaboration and has ability to influence project strategy. Capable of working independently on highly specialized projects with long range objectives. Leads the execution of Quality Deliverables such as project Design & Development Plans, Design Changes, and Design & Usability Validation Plans. Leads the execution of Risk Management deliverables to ensure compliance to ISO 14971 and demonstrates a primary commitment to patient safety. Provide quality and compliance input and coaching for product development and/or post market product sustaining activities, such as design changes, product CE marking, customer complaint investigations, AI requests, NCEP's and CAPA's. Exercises considerable latitude in determining technical objectives of assignments. Selects methods and techniques to lead a project to completion with focus on translating organizational strategy into tactical deliverables. Provides project direction, coaching, and mentoring for engineering and technical team personnel. Develops solutions to complex and diverse technical problems which require the regular use of ingenuity and creativity. Exercises judgment within broadly defined practices and policies in selecting methods, specialized techniques, and evaluation criteria for obtaining results. Proactively investigates, identifies, and implements best-in-class Quality Engineering practices. Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Supports internal and external regulatory audits. Provides technical leadership to business units. Advises management on potential improvements or enhancement to quality systems and processes. Support development, implementation and training of corporate quality initiatives. What we're looking for in you:Minimum Qualification BS in Biomedical, Mechanical Engineering or related degree. Minimum of 8 years of medical device engineering experience. In depth familiarity with the FDA, ISO, MDD, EU MDR and the medical device industry quality requirements associated with product development, design controls, and product risk management. Strong communication and presentation skills. Solid technical writing skills. Travel

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