Principal Design Quality Assurance Engineer

5 days ago

Arden Hills MN, United States myGwork Full time
This job is with Boston Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

Additional Location(s):

Costa Rica-Heredia Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

About 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 (in office minimum three days per week) with the flexibility to be located in Arden Hills, MN or Heredia, Costa Rica.

Your responsibilities include: Promote Cross-Functional collaboration and has ability to influence project strategy. Capable of working independently on highly specialized projects with long range objectives Lead 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 Exercise 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 Provide project direction, coaching, and mentoring for engineering and technical team personnel. Develop 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 Support internal and external regulatory audits Provide 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

Required Qualifications: BS in Electrical Engineering, Mechanical Engineering or related degree Minimum of 7 years of medical device engineering experience or similarly regulated industry 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 Solid technical writing skills Travel

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