Senior Quality Engineer - MedTech Risk & Validation Lead

Becton Dickinson; Tempe (AZ); On-site; USD 110,000 - 160,000; Full time

Job summary

BD in Tempe, AZ seeks a candidate to support product leadership and risk management for combination products, including manufacturability, scalability, and post-launch sustainability. This role involves leading risk assessments, design/process validation, and cross-functional product development activities.

Qualifications include a BS in Engineering and at least five years in engineering or quality engineering within medical devices or pharma, with ISO 13485 and regulatory familiarity.

Qualifications

• BS in Engineering and 5+ years in engineering or quality engineering in medical devices/pharma.
• Experience with risk management and regulatory requirements (ISO 13485, 14971, 21 CFR).
• Pharmaceutical or combination product experience preferred.

Responsibilities

• Provide technical leadership for medical device product development and risk assessments.
• Lead design validation/verification and process validation activities.
• Coordinate product investigations and risk-based decision making.
• Translate design inputs into manufacturing control plans and procedures.
• Support supplier audits and regulatory submissions as needed.
• Contribute to project planning, budgeting, and tracking within Product Development Teams.

Skills

Risk management

Quality engineering

Statistical analysis

Root Cause Analysis

Cross-functional leadership

Test method development

Design validation / verification

Process validation

Regulatory awareness

Problem solving

Education

BS in Engineering

Tools

Statistical software

Design of Experiments

Quality/system qualification tools

Equipment qualifications

Process and design validation

Job description

BD in Tempe, AZ seeks a candidate to support product leadership and risk management for combination products, including manufacturability, scalability, and post-launch sustainability. This role involves leading risk assessments, design/process validation, and cross-functional product development activities.

Qualifications include a BS in Engineering and at least five years in engineering or quality engineering within medical devices or pharma, with ISO 13485 and regulatory familiarity.