Senior Quality Engineer – Medical Devices & Design Controls

SecondWave Systems, Inc.; Saint Paul (MN); On-site; USD 100,000 - 150,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Disability insurance

Life insurance

Paid holidays

Vacation & sick leave

SIMPLE IRA 3% match

Advancement opportunities

Job summary

SecondWave Systems, Inc. is seeking a hands-on Quality Engineer to support development, verification, manufacturing, and ongoing quality system improvements for our medical device products.

Collaborate with Product Development, Manufacturing, Regulatory, Clinical, and Operations to ensure quality is built into the lifecycle from development through production. The role involves design controls, risk management, V&V, process development, nonconformance management, CAPA, supplier quality, and

Qualifications

• Bachelor's degree in Engineering or related technical field.
• 5+ years of quality engineering experience.
• Medical device industry experience preferred.
• Knowledge of ISO 13485 and FDA QSR.
• Knowledge of ISO 14971 risk management.
• Experience with design controls, V&V, CAPA, and change control.
• Root cause analysis and structured problem solving.
• Ability to read engineering drawings and technical documentation.
• Strong communication and organizational skills.
• Ability to work in a fast-paced startup environment.

Responsibilities

• Support quality engineering activities throughout product development lifecycle.
• Maintain design history files and quality records.
• Support risk management activities per ISO 14971.
• Participate in hazard analyses, FMEA, and risk reviews.
• Assist with supplier quality and process validation.
• Contribute to continuous improvement of QMS at SecondWave.
• Ensure regulatory compliance across development and production.

Skills

Quality engineering

Design controls

Risk management

CAPA

Root cause analysis

Reading drawings

Documentation

Communication

Education

Bachelor's degree in Engineering or related field

Tools

Microsoft Office

Job description

SecondWave Systems, Inc. is seeking a hands-on Quality Engineer to support development, verification, manufacturing, and ongoing quality system improvements for our medical device products.

Collaborate with Product Development, Manufacturing, Regulatory, Clinical, and Operations to ensure quality is built into the lifecycle from development through production. The role involves design controls, risk management, V&V, process development, nonconformance management, CAPA, supplier quality, and