Quality Engineer II — Medical Devices Risk & Validation

Becton Dickinson NA; Tempe (AZ); On-site; USD 90,000 - 130,000; Full time

Job summary

Becton Dickinson NA is seeking a Quality Engineering Leader to drive risk assessments, test methods, and validation across a product line in a fast-paced medical device environment. You will coordinate cross-functional teams, lead product investigations, and ensure compliance with ISO 13485 and ISO 14971.

The role involves developing risk management files, supporting regulatory submissions, and traveling up to 25% for audits and project work in a team-oriented setting.

Qualifications

• BS in Engineering required.
• Minimum of two years' experience in engineering or Quality engineering in medical device/pharma or equivalent.
• Knowledge of risk management, design validation/verification, and process validation.

Responsibilities

• Lead risk assessments and test method development.
• Direct component qualifications, design validation/verification, and process validation.
• Lead product investigations and risk-based decision making.
• Translate design inputs into manufacturing control plans and procedures.
• Prepare and present project updates and technical discussions.
• Support supplier audits and regulatory submissions.

Skills

Quality engineering

Risk assessment

Statistical methods

Design validation/verification

Root cause analysis

Cross-functional collaboration

Project leadership

Regulatory awareness

Education

BS in Engineering

Tools

Statistics software

Job description

Becton Dickinson NA is seeking a Quality Engineering Leader to drive risk assessments, test methods, and validation across a product line in a fast-paced medical device environment. You will coordinate cross-functional teams, lead product investigations, and ensure compliance with ISO 13485 and ISO 14971.

The role involves developing risk management files, supporting regulatory submissions, and traveling up to 25% for audits and project work in a team-oriented setting.