Boston Scientific Design Quality Engineer II 

United States, Massachusetts, Marlborough 

410714151

Satyam Baldev Patel
Spencer Gregory Hale

About the Role:

As a Design Quality Engineer II, you will be responsible for ensuring that all requirements are met for the Product Lifecycle Process (PLCP), Risk Management, Design Controls, and Usability Testing. You will work in fast-paced cross-functional teams to maintain and support quality-engineering methodologies, systems, and practices that meet company, customer, and regulatory requirements. You will serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional, and corporate quality goals and priorities.

Key Responsibilities:

• Design Controls and Risk Management:
  • Provide quality and compliance input to project teams for decisions and deliverables (e.g., Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Review, Design V&V, Usability Testing, Process Validation, and Labeling).
  • Support Risk Management planning, updating and maintenance of the product risk documentation (Hazard Analysis, Design FMEA, Task Analysis and Fault Tree Analysis, etc.) in compliance with Boston Scientific procedures and external standards (eg. EN 14971).
  • Support Usability Engineering and planning documentation (eg. EN 62366/ISO 62366)
  • Support the implementation of effective quality assurance, process controls, statistical analyses, and metrics.
• Product Support:
  • Provide key quality trending information and data for Management Review and Complaint Reviews.
  • Interfaces with R&D, Regulatory Affairs, Clinical, Marketing, Process Development and Manufacturing functions in a project team environment
  • Offer quality and compliance input for post-market product sustaining activities, such as design changes, supplier auditing, design concessions, product CE marking, customer complaint investigations, NCEP’s, CAPA’s, PIR’s, and Field Actions.
• Continuous Improvement:
  • Apply systematic problem-solving methodologies (e.g., 5 Why’s analysis, Is-Is Not analysis, Six Sigma) to identify, prioritize, communicate, and resolve quality issues.
  • Lead implementation activities for post-market surveillance, product feedback, and corrective and preventive action programs.
  • Support internal and external audits.

Qualifications:

Minimum Qualifications:

• Bachelor’s degree in mechanical, electrical, or biomedical engineering (or related technical discipline).
• Minimum of 3 years of experience in quality and risk management in a highly regulated industry.
• Familiarity with FDA, ISO, MDD, and medical device industry quality requirements.

Maximum Salary: $ 138300

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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.