Design Assurance Quality Engineer III

Boston Scientific • Georgetown, MA

19h • $82,100 - $156,000 • Hybrid

About The Position

The Design Assurance Engineer directly supports medical devices through operations, product development, and sustaining functions. The role develops, establishes, and maintains quality-engineering methodologies, systems, and practices that meet Boston Scientific, customer, and regulatory requirements. As a Quality representative, the engineer advances awareness, visibility, and communication of quality initiatives in support of departmental, functional, site, divisional, and corporate goals and priorities. The position provides quality engineering support for technical development projects, new product development, sustaining product families, and systems or services.

The role follows a hybrid work model requiring employees to work in the local office at least three days per week. Travel is approximately 10–20%. Relocation assistance and visa sponsorship are not available for this position. The position is considered safety-sensitive and requires prohibited-substance testing.

Requirements

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or a related field.
• At least 3 years of medical device engineering experience.
• Detailed understanding and working knowledge of U.S. and international medical device requirements, including 21 CFR Part 820, the Medical Device Directive (MDD) and Medical Device Regulation (EU MDR), EN ISO 13485, and EN ISO 14971.
• Ability to travel approximately 10–20%.

Nice To Haves

• Strong oral and written communication and presentation skills.
• Ability to collaborate and work on a global team.
• Strong technical expertise in quality engineering principles, design controls, risk management, and problem-solving methodologies.
• Six Sigma or CQE certification preferred.

Responsibilities

• Provide quality and compliance input for post-market product-sustaining activities, including design changes, supplier auditing and surveillance, design concessions, product CE marking and safety certification, customer complaint investigations, NCEPs, CAPAs, PIRs, Field Signals Evaluations, and Field Actions.
• Use systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues, such as 5 Whys, Is-Is Not analysis, and DMAIC.
• Provide quality and compliance input to project teams on decisions and deliverables involving design controls, including Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, Process Validation, and Labeling.
• Champion compliance with company policies, work instructions, and SOPs.
• Support quality assurance, process controls, and metrics using data and statistical analysis to drive improvements and actions for product manufacturing and assembly.
• Support internal and external regulatory audits as required.
• Support collection and analysis of quality-trending information and data for Management Review and Complaint Reviews.
• Understand and support the linkage of field data and Risk Management.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level