Principal Quality Engineer, Design Assurance

Biopharma Asia; New Brighton (MN); On-site; USD 140,000 - 190,000; Full time

Job summary

Johnson & Johnson is hiring a Principal Quality Engineer (Design Assurance) to support the Shockwave Reducer business in New Brighton, MN. The role partners with R&D, Manufacturing, Regulatory Affairs, and Marketing to ensure design and development quality throughout the lifecycle.

The candidate will lead QA for new product development, apply ISO 13485 and FDA requirements, manage DHFs, and mentor engineers. Strong statistical, writing, and regulatory interaction skills are required.

Qualifications

• Bachelor’s degree in Biomedical/Mechanical Engineering or related field with 10+ years in medical devices, or Master’s with 8+ years.
• Experience leading design verification/validation, including protocol approval.
• ISO 13485, FDA QMSR, and ISO regulatory familiarity.
• FMEA, risk management, and design history file oversight.
• Strong statistical methods and data analysis ability.

Responsibilities

• Lead quality assurance for new product development and design verification activities.
• Partner with design teams to ensure ISO 13485 and regulatory compliance.
• Be the SME on regulatory standards, statistics, test design, and acceptance criteria.
• Participate in design reviews and maintain DHFs accurate and inspection-ready.
• Provide oversight of V&V activities, protocols, and reports.

Skills

Quality engineering

Regulatory knowledge

Design Assurance

Risk management

V&V

Education

Biomedical/Mechanical Eng

Master's degree

Tools

Minitab

Job description

Johnson & Johnson is hiring a Principal Quality Engineer (Design Assurance) to support the Shockwave Reducer business in New Brighton, MN. The role partners with R&D, Manufacturing, Regulatory Affairs, and Marketing to ensure design and development quality throughout the lifecycle.

The candidate will lead QA for new product development, apply ISO 13485 and FDA requirements, manage DHFs, and mentor engineers. Strong statistical, writing, and regulatory interaction skills are required.