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. 

The 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 product development teams from product inception through product launch and maintenance and play an active role in the process ownership 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.

Responsibilities:

• Ensures Design Controls is effectively implemented across the MMS business, particularly for the Infusion Solutions Platform

• Serves as subject matter authority on Design Controls for MMS business, particularly for the Infusion Solutions Platform

• Leads continuous process improvements and partners with SME’s on key initiatives

• Ensures consistent application of design controls activities across all elements of the Quality System (e.g. CAPA, Field Actions, etc)

• Identifies IT solutions necessary to support Design Controls and works with the IT Teams to implement system solutions across BD

• Defines metrics and measures for Design Controls

• Establishes training requirements and orchestrates training for Design Controls

• Monitors performance of Design Controls and reports to senior leadership

• Monitors industry surveillance audit outcomes and takes necessary actions to align process to applicable new or revised regulatory requirements and standards

• Monitors internal and external audit observations within BD, identifies the appropriate cause and implements fixes across the enterprise for Design Controls

• Works with standards committee to monitor for external regulatory changes. Determines need for changes to policy, procedure and practices based on regulatory changes and implements where appropriate

• Supports regulatory inspections and audits

• Participate 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.

Primary Work Location and Additional Considerations:

• USA CA - San Diego TC Bldg C&D

• We are interested in every qualified candidate who is eligible to work in the United States. However, we are not able to sponsor visas' at this time.

• We are interested in every qualified candidate who is eligible to work in the United States. However, we are not able to provide Relocation