Engineer II, Quality

Becton Dickinson Medical Devices•San Diego, CA

11d•Onsite

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. Quality Engineer II Job Duties Provides guidance and assistance for project teams to navigate the design control process Develops test methods and sampling plans; collects data; analyzes results; prepares reports; presents findings and makes recommendations based on analysis of data Writes and reviews technical documents such as test protocols, test reports, engineering analysis, drawings, specifications, operating procedures, and audit observations Manages own activities and competing priorities with support from the QE Manager to meet deadlines and resolve problems; identifies and communicates risks affecting own work 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 2 years of design controls experience
Demonstrated managing 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

Provides guidance and assistance for project teams to navigate the design control process
Develops test methods and sampling plans; collects data; analyzes results; prepares reports; presents findings and makes recommendations based on analysis of data
Writes and reviews technical documents such as test protocols, test reports, engineering analysis, drawings, specifications, operating procedures, and audit observations
Manages own activities and competing priorities with support from the QE Manager to meet deadlines and resolve problems; identifies and communicates risks affecting own work
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

Benefits

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You .

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