Senior Design Quality Engineer – Medical Devices (Hybrid)

Boston Scientific; Maple Grove (MN); Hybrid; USD 85,000 - 162,000; Full time

Job summary

Boston Scientific is seeking a Design Quality Engineer at its Maple Grove, MN site. The role focuses on Design Assurance activities to ensure compliance with Design Controls and regulatory standards across the product lifecycle.

You will partner with R&D, Manufacturing, Regulatory, and Operations to embed quality into development and sustaining efforts. The position requires a bachelor’s degree in engineering and 4+ years in a regulated medical device environment, with strong problem-solving and

Qualifications

• Bachelor's degree in engineering or related technical discipline.
• 4+ years in design assurance, new product development or sustaining in medical device industry.
• Self-motivated with problem-solving and action bias.
• Demonstrated use of quality tools/methodologies.
• Ability to work effectively in mixed onsite + remote environment.
• Experience creating detailed technical documents.

Responsibilities

• Lead Design Assurance activities across the product lifecycle, ensuring compliance with design control requirements and regulatory standards.
• Collaborate with R&D, Manufacturing, Regulatory, Operations and Marketing to embed quality objectives in development and sustaining activities.
• Establish, implement and maintain Design Controls based on risk management and user needs.
• Develop and maintain Design History File documentation and traceability.
• Lead Risk Management activities including FMEAs and hazard analyses per ISO 14971.
• Provide Design Quality oversight for verification, validation and usability engineering.

Skills

Quality tools/methodologies

Design Controls

Risk Management

Cross-functional collaboration

Documentation

Education

Bachelor's degree in mechanical, electrical, or biomedical engineering

ISO 13485 understanding

Tools

FDA QSR 21 CFR Part 820

Job description

Boston Scientific is seeking a Design Quality Engineer at its Maple Grove, MN site. The role focuses on Design Assurance activities to ensure compliance with Design Controls and regulatory standards across the product lifecycle.

You will partner with R&D, Manufacturing, Regulatory, and Operations to embed quality into development and sustaining efforts. The position requires a bachelor’s degree in engineering and 4+ years in a regulated medical device environment, with strong problem-solving and