Senior Quality Engineer, MedTech – Risk & Transfer Leader

Regulatory Jobs; Tempe (AZ); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Career development opportunities

Job summary

BD is seeking a seasoned Quality/Engineering professional to support product leadership and risk management for new product development and sustaining activities for combination products. You will influence manufacturability, scalability, transfer, and post-launch sustainability.

Education includes a BS in Engineering with at least five years in medical device or pharmaceutical engineering. Travel up to 25% may be required as projects evolve.

Qualifications

• BS in Engineering
• Minimum of five years’ experience in engineering or Quality engineering within the medical device, pharmaceutical, or equivalent industry
• Pharmaceutical or combination product experience preferred

Responsibilities

• Provide technical leadership in medical device operations and QA
• Lead risk assessments and test methods development
• Lead component qualifications, design validation/verification and process validation
• Lead product investigations and risk-based decision making
• Translate design inputs into manufacturing control plans
• Support regulatory submissions and compliance with ISO 13485, ISO 14971, 21 CFR 210/211/820
• Coordinate product development activities and participate in project planning and audits

Skills

Risk management

Quality engineering

Process validation

Statistical methods

Regulatory knowledge

Cross-functional leadership

Documentation skills

Root cause analysis

Education

BS in Engineering

Job description

BD is seeking a seasoned Quality/Engineering professional to support product leadership and risk management for new product development and sustaining activities for combination products. You will influence manufacturability, scalability, transfer, and post-launch sustainability.

Education includes a BS in Engineering with at least five years in medical device or pharmaceutical engineering. Travel up to 25% may be required as projects evolve.