Lead Quality Engineer - Medical Device Risk & Validation

Regulatory Jobs; Tempe (AZ); On-site; USD 120,000 - 150,000; Full time

Job summary

BD is seeking a skilled Quality Engineer to support product leadership and risk management for new product development and sustaining activities for combination products at the Tempe site. The role focuses on manufacturability, transfer, and post-launch support.

The candidate will lead risk assessments, design validation/verification, and process validation, ensuring alignment with ISO 13485, ISO 14971 and relevant US regulatory standards.

Qualifications

• Knowledge of risk management and quality engineering in medical devices.
• Experience with design controls, verification and validation.
• Familiarity with ISO 13485, ISO 14971 and 21 CFR applicable.

Responsibilities

• Leads development of risk assessments and test methods.
• Leads component qualifications, design validation / verification and process validation.
• Leads product investigations and risk-based decisions.
• Supports translation of design inputs into manufacturing control plans.
• Coordinates product development activities for a product line.

Skills

Quality engineering

Risk assessment

Process validation

Design controls

Regulatory knowledge

Statistical methods

Cross-functional leadership

Documentation

Education

BS in Engineering

Tools

CAPA tools

Job description

BD is seeking a skilled Quality Engineer to support product leadership and risk management for new product development and sustaining activities for combination products at the Tempe site. The role focuses on manufacturability, transfer, and post-launch support.

The candidate will lead risk assessments, design validation/verification, and process validation, ensuring alignment with ISO 13485, ISO 14971 and relevant US regulatory standards.