Boston Scientific Principal Design QA Engineer 

United States, Massachusetts, Marlborough 

757571015

Spencer Gregory Hale

About this role:

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 three days per week.

Your responsibilities include:

• Provide quality and compliance input and coaching for product development and/or post market product sustaining activities, such as EUMDR Notified Body questions, Product Inquiry Reports (PIR), Additional Information (AI) requests, CE marking, Design Changes, NCEP’s and CAPA’s.
• 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.
• 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 <10%, if required

Preferred Qualifications

• 10+ years of medical device engineering experience preferred.
• MS preferred

Among other requirements, Boston Scientific maintains specificprohibited substancetest requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to aprohibited substancetest as a requirement. The goal of theprohibited substancetesting is to increase workplace safety in compliance with the applicable law.