Senior Quality Engineer - Medical Devices Risk Lead

BD; Tempe (AZ); On-site; USD 90,000 - 130,000; Full time

Job summary

BD in Tempe, AZ is seeking a Senior Quality Engineer to manage risk and sustain activities for combination products in medical devices. The role emphasizes leadership in risk assessments, design and process validation, and collaboration with cross-functional teams.

You will support regulatory submissions and drive quality improvements across manufacturing and development, with travel up to 25% as needed.

Qualifications

• BS in Engineering is required.
• Minimum of five years’ experience in engineering or quality engineering in the medical device, pharmaceutical, or equivalent industry.
• Pharmaceutical or combination product experience preferred.

Responsibilities

• Provide technical leadership in medical device manufacturing, process development, and QA.
• Lead development of risk assessments and test methods.
• Lead component qualifications, design validation / verification, and process validation.
• Lead product investigations and risk-based decision making.
• Support translation of design inputs into manufacturing control plans.
• Coordinate and direct product development activities for a product line.
• Represent QA on cross-functional Product Development Teams for new products.

Skills

Risk management

Quality engineering

Statistical analysis

Cross-functional leadership

Problem solving

Oral and written communication

Regulatory knowledge

Education

BS in Engineering

Job description

BD in Tempe, AZ is seeking a Senior Quality Engineer to manage risk and sustain activities for combination products in medical devices. The role emphasizes leadership in risk assessments, design and process validation, and collaboration with cross-functional teams.

You will support regulatory submissions and drive quality improvements across manufacturing and development, with travel up to 25% as needed.