Design Quality Engineer III
About The Position
We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. Design Quality Engineer III Job Duties Acts as a resource for less experienced Quality Engineers, providing mentorship, guidance and training as needed Develops test methods and sampling plans; designs experiments; collects data; analyzes results; prepares reports; presents findings and makes recommendations based on analysis of data Writes and interprets technical documents such as test protocols, test reports, engineering analysis, drawings, specifications, operating procedures, and audit observations Plans and schedules own activities; manages competing priorities to meet deadlines and resolve problems; identifies and communicates risks affecting own work Shares lessons learned with the Quality team and cross functional teams Leads cross functional teams as required; facilitates team effectiveness Participates in and supports audits: FDA, Notified Body and internal Supports product launches by working with operations, regulatory affairs, technical service, and receiving inspection to ensure successful transition from development to full scale manufacturing Conducts root cause investigations of product complaints and quality issues; initiates corrective actions; monitors implementation and effectiveness of corrective actions Participates in the CAPA and Situational Analysis process through ownership of corrections and corrective actions
Requirements
- Bachelor's degree in Engineering or related field plus 3 years of design controls experience
- Demonstrated leadership skills including ability to manage multiple projects simultaneously, work independently, and make effective presentations
- Proficiency in Microsoft Office Suite; statistics based programs (e.g. Minitab, JMP, etc)
- Strong analytical, problem solving, and project management skills
- Ability to read, write, speak, and understand English
Responsibilities
- Acts as a resource for less experienced Quality Engineers, providing mentorship, guidance and training as needed
- Develops test methods and sampling plans; designs experiments; collects data; analyzes results; prepares reports; presents findings and makes recommendations based on analysis of data
- Writes and interprets technical documents such as test protocols, test reports, engineering analysis, drawings, specifications, operating procedures, and audit observations
- Plans and schedules own activities; manages competing priorities to meet deadlines and resolve problems; identifies and communicates risks affecting own work
- Shares lessons learned with the Quality team and cross functional teams
- Leads cross functional teams as required; facilitates team effectiveness
- Participates in and supports audits: FDA, Notified Body and internal
- Supports product launches by working with operations, regulatory affairs, technical service, and receiving inspection to ensure successful transition from development to full scale manufacturing
- Conducts root cause investigations of product complaints and quality issues; initiates corrective actions; monitors implementation and effectiveness of corrective actions
- Participates in the CAPA and Situational Analysis process through ownership of corrections and corrective actions
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
