Design Quality Engineer

BD

Warwick, RI, United States
Fully remote
Quality engineering for medical devices
Design control and risk management
Regulatory submissions including 510k and pma
BD is a global medical technology company focused on advancing the world of health through innovative MedTech products and collaborative teams

Job Summary

  • BD is a global medical technology company focused on advancing the world of health through innovative MedTech products and collaborative teams.
  • The role involves leading quality engineering initiatives, developing test protocols for regulatory submissions, and supporting new product development and sustaining projects for implantable medical devices.
  • BD offers a culture that supports learning, growth, and authenticity, emphasizing teamwork, accountability, and making a positive impact on global health.

Matching Summary

BD is a global medical technology company focused on advancing the world of health through innovative MedTech products and collaborative teams.

Skills & Requirements

Must-have

  • Quality Engineering for medical devices
  • Design control and risk management
  • Regulatory submissions including 510K and PMA
  • Statistical analysis and design of experiments
  • Process and supplier quality management
  • CAPA implementation and complaint investigation

Nice-to-have

  • Collaboration with R&D teams
  • Mentorship and technical leadership
  • Experience with combination products
  • Knowledge of absorbable technologies
  • Interaction with surgeons
  • Use of statistical software like MiniTab
  • Supportive team culture and continuous improvement

Key Requirements

  • Bachelor Degree in Engineering or Technical Sciences with 2 years experience
  • Masters Degree with 1 year experience in Quality Engineering
  • Experience in design controls and product/process validation
  • Knowledge of FDA QSR, ISO13485, ISO14971, ISO 9001
  • 15-20% travel availability

Work Rights

Must be fully vaccinated against COVID-19 as condition of employment

Tailored Resume

Cover Letter