Senior Design Assurance Engineer - Medical Devices

Boston Scientific; Marlborough (MA); Hybrid; USD 82,000 - 156,000; Full time

Job summary

Boston Scientific seeks a Design Assurance Engineer to support medical devices through operations, development and sustaining activities. You will implement quality-engineering methodologies meeting regulatory requirements and act as a quality representative across projects.

The role follows a hybrid work model with in-office collaboration at least three days per week, and requires knowledge of US and international medical device regulations, design controls, risk management and process

Qualifications

• Strong understanding of US and international medical device requirements including 21 CFR part 820, MDD/EU MDR, EN ISO 13485 and EN ISO 14971.
• Travel approximately 10-20%.
• Experience in medical device engineering and quality assurance practices.
• Ability to apply design controls and quality methodologies in projects.

Responsibilities

• Provide quality and compliance input for post market product sustaining activities including design changes and supplier surveillance.
• Apply systematic problem-solving methodologies (e.g., 5 Whys, DMAIC) to quality issues.
• Provide quality input to project teams on design controls, design reviews, and verification/validation activities.
• Champion compliance with company policies, SOPs and work instructions.
• Support quality metrics and data analysis for manufacturing and assembly improvements.
• Assist internal and external regulatory audits as required.
• Analyze quality data and risk management linkage for management reviews.

Skills

Quality engineering

Regulatory knowledge

Problem solving

Communication

Education

Bachelor's degree in Biomedical Engineering, Mechanical Engineering or related degree

Job description

Boston Scientific seeks a Design Assurance Engineer to support medical devices through operations, development and sustaining activities. You will implement quality-engineering methodologies meeting regulatory requirements and act as a quality representative across projects.

The role follows a hybrid work model with in-office collaboration at least three days per week, and requires knowledge of US and international medical device regulations, design controls, risk management and process