BD (Becton, Dickinson and Company) Sr Development Quality Engineer in San Jose, California
Job Description Summary
Be part of something bigger!
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most ambitious global health issues.
As advised by the Quality director, the NPD Sr Development Quality Engineer provides quality leadership and support of new product development and technology research projects for Biosciences Instruments and Reagents. This person will make sure that the design control requirements are implemented and followed, will support multiple product development projects and will ensure that the quality objectives are met during the product development life cycle.
This role will be an active mentor and coach to ensure products meet quality standards consistent with both Corporate and Business policies, while meeting all design control and other regulatory requirements. Specifically, this individual will use standard methodologies in support of multi-functional team leadership to drive excellence in areas such as customer requirement definition, product design and development and commercial launch. The staff quality engineer will ensure a mentality of collaboration, execution and continuous improvement while ensuring effective formal and informal communication mechanisms are employed.
Key Responsibilities for this Role:
Independently manages and monitors quality needs of the new product project and all major projects as assigned. Calls out resource issues, constraints and delays to the quality director, whom this position reports into. Oversees and provides guidance to ensure that all activities are performed in accordance with quality system and regulatory requirements. Applies and mentors/coaches the application of technical principles, theories, concepts and quality tools to complex systems and process. Manages quality engineering support of Design Control activities, including quality planning, design verification & validation activities, design reviews, design transfer etc. Performs, mentors and coaches others on effective root cause investigations and corrective actions to maintain effective and compliant quality systems. Lead implementation and utilization of quality tools such as six sigma, risk management, SPC, root cause analysis, and DOE. Required to present management status updates.
Policy and Strategy: Executes established strategy and direction associated with design control, change control, risk management, validations, supplier qualifications, SAs, CAPAs, statistics & sampling plans, and regulations.
Sphere of Influence
Interacts internally with peers to negotiate and resolve conflicts. Understands and works to improve effectiveness of the BD matrix.
Primarily focused within the Biosciences organization.
Directs and controls the activities of quality engineers supporting core team objectives.
Advances the talent bench strength of the company and builds bridges across the various departments to share and develop talent.
Impact of Decisions
Decisions impact Biosciences and affect the financial, associate, or public relations position of BD.
- Minimum of B.S. in Engineering, Science (Chemistry or Physics). Master of Science in Engineering, Science is desired.
Knowledge & Experience
A minimum of 5 years of experience in quality engineering or similar engineering discipline with a minimum of 3 years of experience supporting product development lifecycle (R&D, manufacturing, etc.) in Medical Device industry with responsibilities for quality management.
Strong understanding and implementation experience of design controls, 21CFR820, ISO13485, ISO 9001, ISO14971, IVDR and other applicable medical device regulations.
Sound understanding of basic quality engineering sciences, including statistical process control (SPC) methods and application, quality planning, failure analysis investigation, risk management and process and software validation.
Practical knowledge in design control and process control in a regulated industry.
Have a strong track record working with cross-functional product development teams.
Expert in delivering business critical goals within a phase gate based product development process.
Expert in the development of risk management, applications of six sigma and daily management tools to drive cohesion and velocity.
Strategic thinking and leadership skills; ability to develop strategies into clear actionable objectives and measurements. Ability to understand implications and impacts across multiple functions.
Skilled at facilitating team dynamics.
Possess the skills and aptitude to engage and influence other functions involved in the development of new products.
Expertise in influencing without authority and dealing effectively with ambiguity.
Drive for accountability within self and project team.
Demonstrated project management skills.
Proven to make timely critical decisions.
Experience preparing and understanding technical documentation such as engineering drawings, operating procedures, work instructions, validations etc.
Strong communication - communicate effectively in writing and orally, to organize work and to achieve results when working alone or in teams.
CQE and/or CMQ/OE preferred.
Six-Sigma certification is preferred.
Strong communication, problem solving, organizational and interpersonal skills.
Travel Requirements - 5% to 10% both internationally and domestically once approved to resume.
Work Location - San Jose with the opportunity to work remotely with typically one to two days within office. In office requirements subject to change based on project needs.
Requires in-depth knowledge of functional area, strategies, and BD’s goals.
Responsible for executing to the business quality system.
Has full understanding of quality and regulatory principles.
Click on Apply if this sounds like you!
Why join us?
A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
To learn more about BD visit https://jobs.bd.com/
Primary Work Location
USA CA - San Jose