Quality Technician

Senior Staff Design Controls Process Engineer

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 Med Tech 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 Senior Staff Design Controls Process Engineer is accountable for influencing design control process activities for product development and product maintenance through the application of Quality engineering skills for medical devices. This person will support Engineers 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 business unit policies, while meeting all design control and other regulatory requirements.

This individual monitors internal and external regulatory observations and trends for hardware and software product development.

In accordance with all applicable federal, state and local laws/regulations and Corporate BD, procedures and guidelines, this position is responsible for:

• Ensuring Design Controls is effectively implemented across Dispensing Solutions Platform
• Participating in Collaborative Community for Design Controls
• Serving as subject matter authority on Design Controls for Dispensing Solutions Platform
• Leading continuous process improvements and partnering with SME's on key initiatives
• Ensuring consistent application of design controls activities across all elements of the Quality System (e.g. CAPA, Field Actions, etc)
• Identifying IT solutions necessary to support Design Controls and working with the IT Teams to implement system solutions across BD
• Defining metrics and measures for Design Controls
• Establishing training requirements and orchestrating training for Design Controls
• Monitoring performance of Design Controls and reporting to senior leadership
• Monitoring industry surveillance audit outcomes and taking necessary actions to align process to applicable new or revised regulatory requirements and standards
• Monitoring internal and external audit observations within BD, identifying the appropriate cause and implementing fixes across the enterprise for Design Controls
• Working with standards committee to monitor for external regulatory changes. Determining need for changes to policy, procedure and practices based on regulatory changes and implementing where appropriate
• Supporting regulatory inspections and audits
• Participating collaborative community (cross site/cross functional network of SMEs) which will support and drive change for Design Controls

Education and Experience:

• Requires a minimum of a BS/MS degree in life science, engineering or other relevant discipline.
• At least 8 years of experience in a Class I/II/III medical device with specific experience in Design Controls
• Strong background in Design Controls in relation to product design and development.
• Strong background in Software compliance requirements
• Proven ability as a change agent to drive improvements across a large organization.
• Strong technical writing experience required.
• Excellent problem solving and analytical skills.
• Ability to develop creative approaches and solutions necessary to resolve complex problems.
• Strong communicator capable of interfacing at senior levels.
• Understanding of the application of quality systems to the medical device industry.
• Ability to work effectively and influence leading decision makers across diverse areas of BD and manage complex structures.
• Articulate with ability to influence others and significantly promote and/or negotiate in situations that involve recognizing and responding to underlying concerns where others need to be persuaded to accept compromised solutions.
• Opportunity to work…