Job Description Summary

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. 

Sr. Quality Engineer, Product Development Processes

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 Sr. Quality Engineer, Product Development Processes is responsible for applying quality engineering skills for medical devices in leading, planning and implementing businesses process projects including the areas of design control, risk management, and change control.

This position will work closely with cross-functional teams to create, improve, and implement total product life cycle business processes for BD MMS products and will play an active role in improvement, remediation, and training projects to ensure products meet quality standards consistent with both Corporate and business unit policies, while meeting all design control, risk and other regulatory requirements.

Responsibilities:

• Supports Business Process Leadership with implementation of strategic product development and post-market process development initiatives (e.g. CAPAs, Field Actions, corporate initiatives, and continuous improvement).

• Leads targeted business process projects and partners with SME’s on key initiatives

• Collaborates with R&D engineering, medical affairs, regulatory, quality systems, product quality and risk management, and other functions as necessary to ensure stakeholder engagement and alignment with business processes Including design control, risk management, and change control processes.

• Adheres to project and regulatory timeline expectations.

• Exhibits technical leadership skills including an understanding of medical device product development and operations (e.g., medical device manufacturing, process development, quality assurance) 

• Participates in and assists with facilitation of training for business processes and procedures. 

• Supports regulatory inspections and audits

• Complies with company procedures and policies, government regulations. 

• Participate collaborative community (cross site/cross functional network of SMEs) which will support and drive change for process improvements

• Perform any other tasks as assigned.  

Education and Experience:

• BS in technical field with 4 years or MS in technical field with 2 years of Quality, Risk Management, Design Control or Engineering in a Class I/II/III medical device experience.

• Experience with Design Controls regulation including ISO 13485 and CFR 820.30

• Experience with ISO 14971 Risk Management (example: Hazard Analysis, Process FMEA etc.), preferred.

• Cybersecurity and computer software validation experience, preferred.

• Proven ability as a change agent to drive improvements across a large organization.

• Strong project management skills.

• Strong technical writing experience required. 

• Have experience in managing quality improvement projects would be an added advantage. 

• Able to effectively multi-task and work independently with a high level of initiative.

• Excellent problem solving and analytical skills.

This position will typically work remotely with potential for minimal need to travel (anticipated to be approximately 10-20%) 

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 fo