Job Description Summary

Quality Engineer II: design, development, manufacturing, and post-market risk management

Job Description

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. 

The Quality Engineer II position supports the design, development, manufacturing, and post-market risk management

Job Responsibilities

Quality Engineer II Job Duties

• Reviews and investigates unanticipated label identified during verification and feasibility testing

• Develops test methods and sampling plans; 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

• 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

• Participates in risk management activities and the risk management file

Minimum Requirements:

• Bachelor's degree in Engineering

• Minimum 2 years of design controls experience in medical device industry

• 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

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.  

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.  

To learn more about BD visit https://bd.com/careers 

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without reg