Senior Quality Engineer — Medical Devices & Risk Leadership

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

Job summary

BD, a leading medical technology company, seeks a Quality Engineer to support product leadership and risk management for new product development and sustaining activities for combination products. The role includes manufacturability, scalability, transfer, and post-launch sustainment.

Responsibilities cover risk assessments, design validation, QA support, supplier audits, and regulatory submissions with up to 25% travel. Primary work location is Tempe, AZ, USA.

Qualifications

• BS in Engineering.
• Minimum of five years' experience in engineering or Quality engineering in the medical device/pharma industry.
• Pharmaceutical or combination product experience preferred.

Responsibilities

• Provide technical leadership in medical device operations including manufacturing, process development, QA.
• Lead risk assessments and test method development.
• Lead component qualifications, design validation/verification.
• Lead product investigations and risk-based decisions.
• Assess product changes against design and manufacturing controls.
• Support translation of design inputs into manufacturing control plans.
• Develop procedures to comply with standards.
• Direct all product development activities for a product line.
• QA representation on PD Teams and Design Reviews.
• Prepare and present project updates and technical discussions.
• Participate in project planning, budgeting, scheduling, and tracking.
• Support supplier audits and regulatory submissions.
• Travel up to 25%.

Skills

Risk management

Quality engineering

Root cause analysis

Statistics

Test method development

Process validation

Regulatory knowledge

Cross-functional leadership

Education

BS in Engineering

Job description

BD, a leading medical technology company, seeks a Quality Engineer to support product leadership and risk management for new product development and sustaining activities for combination products. The role includes manufacturability, scalability, transfer, and post-launch sustainment.

Responsibilities cover risk assessments, design validation, QA support, supplier audits, and regulatory submissions with up to 25% travel. Primary work location is Tempe, AZ, USA.