Senior Design Quality Engineer

Becton Dickinson Medical Devices • Brea, CA

2d • Onsite

About The Position

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 o ur 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 is accountable for supporting new product development and product maintenance 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 Business Unit policies while meeting all design control and other regulatory requirements. Job Summary: Provides support/mentoring/coaching for application of technical principles, theories, concepts and quality, tools and systems. Develops technical solutions to complex problems which require the regular use of technical knowledge, experience, ingenuity, and creativity. List a core team member for complex design control / process control projects. Can serve as a CAPA expert. Modifies methodologies and procedures, ensuring continuous improvement of desired outcomes. Supports quality system audits. Provides input to the management review process May perform other duties as required Scope of Responsibilities: Develops advanced technological ideas and guides their development into a final product, process or business opportunity. Ensures the accurate and actionable recording of data for the making of decisions as well as to document development work Contributes to long-range business strategies, choosing disciplines and methods appropriate to the work content and context Outputs contribute to reduced cycle times, improved effectiveness and furthering the achievement of goals critical to company objectives

Requirements

• Bachelor’s Degree in Engineering or Science related
• Minimum 5 years of experience supporting design assurance for medical devices
• Design controls, change controls, risk management, auditing and CAPA experience required.
• Extensive knowledge of applicable regulatory, Corporate and/or Unit requirements.
• Applicable Regulatory and Industry standards (21-CFR-820, ISO 13485, MDD, MDR, ISO 14971,ISO 10993, etc.)
• Quality Engineering tools, Statistics, Problem Solving, strong Interpersonal Skills, Leadership, all forms of Communication

Nice To Haves

• ASQ Certificate(s) desirable (but not required)
• Design for Six Sigma preferred

Responsibilities

• Provides support/mentoring/coaching for application of technical principles, theories, concepts and quality, tools and systems.
• Develops technical solutions to complex problems which require the regular use of technical knowledge, experience, ingenuity, and creativity.
• List a core team member for complex design control / process control projects.
• Can serve as a CAPA expert.
• Modifies methodologies and procedures, ensuring continuous improvement of desired outcomes.
• Supports quality system audits.
• Provides input to the management review process
• Develops advanced technological ideas and guides their development into a final product, process or business opportunity.
• Ensures the accurate and actionable recording of data for the making of decisions as well as to document development work
• Contributes to long-range business strategies, choosing disciplines and methods appropriate to the work content and context
• Outputs contribute to reduced cycle times, improved effectiveness and furthering the achievement of goals critical to company objectives

Benefits

• At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You .

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees