Quality Engineer II: Medical Device Risk & Validation

Regulatory Jobs; Tempe (AZ); On-site; USD 90,000 - 120,000; Full time

Job summary

BD in Tempe, AZ is seeking a Quality Engineer to lead risk assessments, design validation, and component qualification for medical device programs. The role emphasizes technical leadership, process validation, and strong adherence to ISO 13485 and ISO 14971 standards.

You will collaborate across product development teams, prepare technical submissions, support supplier audits, and drive improvements. Travel up to 25% may be required, and a BS in Engineering with at least two years in quality or

Qualifications

• Knowledge of quality engineering principles and tools.
• Experience with risk management files and design validation.
• Ability to lead cross-functional teams.
• Strong analytical and problem-solving skills.
• Understanding of regulatory requirements incl. ISO 13485, ISO 14971.

Responsibilities

• Lead development of risk assessments and test methods.
• Direct qualification and validation activities for components and processes.
• Support regulatory submissions and internal supplier audits.
• Develop and present project updates and technical discussions.
• Coordinate product development activities and budget/schedule tracking.
• Travel up to 25% for business.

Skills

Quality engineering

Risk assessment

Statistical analysis

Cross-functional leadership

Documentation

Education

BS in Engineering

Two years in medical device/quality engineering

Job description

BD in Tempe, AZ is seeking a Quality Engineer to lead risk assessments, design validation, and component qualification for medical device programs. The role emphasizes technical leadership, process validation, and strong adherence to ISO 13485 and ISO 14971 standards.

You will collaborate across product development teams, prepare technical submissions, support supplier audits, and drive improvements. Travel up to 25% may be required, and a BS in Engineering with at least two years in quality or