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. 

As directed by the Quality Manager, the Senior Quality Engineer will be a member of the Advanced Access Devices (AAD) platform and is accountable for product maintenance and new product development through the application of Quality engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and unit policies, while meeting all design control and other regulatory requirements.

Responsibilities:

• Provide guidance and Quality oversight to ensure establishment and execution of robust design control programs aligned with regulatory requirements and industry standards.

• Support new product development and existing product sustaining activities to ensure work follows proper design
  control. Ensure controls meet BD and FDA regulatory requirements by actively participating on product development
  teams and identifying Quality needs, product improvements and customer requirements.

• Ensures adequate design control documentation and records are maintained to support life cycle of design history.

• Support new product development execution of design control and ensure tasks are completed adequately to include project
  planning, design inputs, critical to quality characteristics, risk analysis, design reviews, validations, verifications, and
  design history files and other activities as needed.

• Provide guidance and training to cross-functional associates to help increase knowledge of regulations and
  standards for Devices and Combination Products.

• Responsible to evaluate design verification results and data utilizing statistical analysis to ensure design delivers an
  acceptable quality level during manufacturing with properly established product specifications.

• Ensures the design is appropriately specified and established before transferring into manufacturing to avoid increased risk.

• Review and authorize Quality approval for new product and/or device design specifications including product
  performance specifications, test methods, acceptance criteria, and release.

• Review and assess work performed by R&D and other BD business units to help ensure Quality issues with device(s) or component(s) are adequately addressed and when needed corrective actions are taken to prevent recurring quality issues.

• Work with Validation team providing Quality Engineering support for Product and/or Device transfer, Scale-Up, and
  Process Validation.

• Lead or participate in ISO 14971 Risk Management activities appropriate to the initiative or situation.

• Monitor quality data from Product Incident Report process, Manufacturing reports, Service reports and customer
  input. Identifies, investigates, troubleshoots and resolves identified quality issues independently or by working with
  Field Assurance, Manufacturing, Engineering, Regulatory and Biostatics.

• Initiate Corrective and Preventative Action plans and perform efficacy follow up.

• Conduct as needed supplier evaluations and meet with suppliers to establish required controls to meet BD and
  regulatory requirements.

• Participate as assigned with supplier capability and internal audits as a means of evaluating effectiveness of GMPs
  and established Quality Systems.

• Support Regulatory Affairs, as appropriate, by providing input for submissions or response to agency queries.
  Support regulatory inspections as needed.

• Lead investigation and Field activities relating to Field Corrective Actions, when needed.

​Qualifications:

• Bachelor’s degree in STEM and six (6) years of engineering experience, OR Master’s degree in STEM and four (4) years of engineering experience required. Design Controls, Risk Management and Change Controls is required.

• Experience in medical device indus