Quality Engineer II — MedTech Risk & Validation Lead

Becton, Dickinson and Company (BD); Tempe (AZ); On-site; USD 90,000 - 120,000; Full time

Job summary

Becton, Dickinson and Company (BD) is seeking a Quality Engineer to lead risk assessments, design validation, and test method development for medical devices in our Tempe, Arizona operations. The role emphasizes cross-functional teamwork, regulatory compliance, and process improvements.

You will develop risk-based decisions, support supplier audits, and contribute to product development activities. A BS in Engineering and at least two years in quality or engineering within the medical device or

Qualifications

• BS in Engineering or equivalent experience in medical device/quality engineering
• Experience in risk management, design validation/verification, and process validation
• Familiarity with ISO 13485 and ISO 14971 regulatory requirements
• Proficiency with Quality Engineering tools e.g., sampling plans, RCA, statistics

Responsibilities

• Provide technical leadership in medical device operations and design validation
• Develop risk assessments and test methods for product lines
• Lead component qualifications and design validation/verification activities
• Support product investigations and regulatory submissions
• Coordinate development activities with cross-functional teams
• Travel up to 25% for business needs

Skills

Risk assessment

Root cause analysis

Statistics

Test protocols

Regulatory knowledge

Cross-functional leadership

Product development

Education

Bachelor of Science in Engineering

Electrical Engineering degree (preferred)

Tools

Equipment qualification

Validation methods

Job description

Becton, Dickinson and Company (BD) is seeking a Quality Engineer to lead risk assessments, design validation, and test method development for medical devices in our Tempe, Arizona operations. The role emphasizes cross-functional teamwork, regulatory compliance, and process improvements.

You will develop risk-based decisions, support supplier audits, and contribute to product development activities. A BS in Engineering and at least two years in quality or engineering within the medical device or