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Design Quality Engineer II

Boston Scientific

Boston Scientific

Design, Quality Assurance
Marlborough, MA, USA
Posted on Thursday, June 27, 2024

Recruiter: Spencer Gregory Hale

Design Quality Assurance Engineer II

About the role:

Boston Scientific is a worldwide and diverse company who puts patients first. As an industry leader in kidney stone management, the Urology divisional team is on a mission to provide urologists with products that offer the best quality, functionality, and flexibility he/she/they need to treat their patients. As a Design Quality Assurance Engineer II, you’ll be at the heart of that mission by working with high-performing cross-functional teams to primarily sustain commercialized Visualization products, including medical electrical systems (MES). He/she/they will serve as a Quality representative who can directly impact patient care by ensuring the safety, quality, post market performance and compliance of the visualization franchise products are maintained while continuously improving their value. He/she/they will interface with cross-functional teams to complete sustaining projects, design control deliverables, and activities to ensure our products continue to meet state of the art regulatory standards and user needs.

Your responsibilities will include:

  • Act as an effective leader or cross-functional team member in supporting quality disciplines, decisions, and practices.
  • Effectively works with and influences cross-functional teams during the Design Change process to ensure proposed changes to products are systemically / thoroughly analyzed, assessed, controlled and implemented appropriately (i.e., EN 13485 / CFR820).
  • Support planning, updating and maintenance of product Risk Management documentation (Hazard Analysis, Design FMEA, Task Analysis and Fault Tree Analysis, etc.) in compliance with Boston Scientific procedures and external standards (i.e., EN 14971).
  • Support Usability Engineering and planning documentation (i.e., EN / ISO 62366 and IEC 606061-1-6).
  • Interface with the core team and support manufacturing operation efforts / changes to ensure they meet or exceed internal and external requirements.
  • Apply sound, systematic problem-solving methodologies (e.g., 5 Whys analysis, Is-Is Not analysis, DMAIC problem solving methodologies) in identifying, prioritizing, communicating, and resolving quality issues in a timely manner.
  • Supporting post market activities ensuring our products meet patient, customer, product performance, and quality system expectations through risk-based assessment of post-market signals.
  • Support internal and external regulatory audits as required.

What we’re looking for in you:

Required Qualifications:

  • Minimum of a Bachelor’s Degree in mechanical, electrical, or biomedical engineering (or other related technical discipline).
  • Minimum of 2 years of related experience.
  • Travel approximately <10%

Preferred Qualifications:

  • Experience in the Medical Device industry (quality and risk management) and medical electrical systems.
  • Detailed understanding of ISO 13485, ISO 14971, and Quality System Regulations.
  • Skillful problem solver, capable of facilitating the problem-solving process and driving to solutions in a timely manner.
  • Ability to work in a fast paced, dynamic environment while promoting / fostering cross-functional teamwork.
  • Strong communication skills (verbal & written)

Requisition ID: 585716

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.