Becton, Dickinson and Company

Staff Quality Engineer - Design Assurance

Becton, Dickinson and Company • $100K — $130K *
Durham, NC 27713In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
3 weeks ago
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering or a related technical field.
  • 8 years of experience supporting R&D development with a focus on design controls in regulated environments.
  • Preferred experience supporting complex system integrations and working with cross-functional design teams.
  • Thorough understanding of risk management and design for manufacturability, serviceability, and reliability.
  • Proficiency in organizational skills and attention to detail.

Responsibilities

  • Serve as the primary Quality representative for New Product Development (NPD) and sustaining programs.
  • Manage all quality aspects of design controls, including planning, verification, validation, and compliance support.
  • Provide guidance on quality system requirements as a subject matter expert throughout the product lifecycle.
  • Collaborate with Program Managers to ensure timely completion of design deliverables.
  • Identify opportunities for process improvements and implement necessary plans of action.
  • Ensure completeness and accuracy of Design History Files (DHF) and product technical documents.
  • Participate actively in design reviews and facilitate cross-functional collaboration for continuous improvement.

Benefits

  • Emphasis on on-site collaboration to enhance creativity and innovation.
  • A minimum of 4 days per week in the office to support operational excellence and culture.
  • Recognition of the need for flexibility and work-life balance in workplace arrangements.
Full Job Description
Job Description

The Staff Quality Engineer is a key member of the New Products Development Team and is responsible for Design Control activities from research through product launch. This position ensures that quality engineering principles are applied to new product development and sustaining engineering projects.

Responsibilities:
  • Serve as the primary Quality representative for New Product Development (NPD) and sustaining programs, partnering closely with Core Teams from concept through commercialization.
  • Own and manage all quality aspects of design controls, including quality planning, verification and validation (V&V), risk management, and regulatory/compliance support.
  • Act as a design controls subject matter expert, providing guidance and clarity to cross-functional teams on quality system requirements throughout the product lifecycle.
  • Collaborate closely with Program Managers to ensure design deliverables are completed on time and ready for limited commercial or general release.
  • Partner with fellow Quality Engineers to ensure robust verification of design requirements and specifications.
  • Monitor and ensure ongoing compliance with company policies, procedures, and applicable international standards.
  • Review and approve Change Orders (COs) and Electronic Release Authorizations (ERAs) for new releases and design enhancements.
  • Identify opportunities for quality and process improvement, initiates and follows through on plans of action necessary for implementation.
  • Actively contribute to product requirements development, system hazard analyses, and formal design reviews.
  • Ensure Design History Files (DHFs) and product technical files are complete, accurate, and audit-ready.
  • Drive continuous improvement initiatives by facilitating and leading cross-functional collaboration.
  • Demonstrate strong knowledge of quality engineering principles, policies, and best practices across the product development lifecycle.
  • Apply a solid understanding of regulatory requirements (cGMP, FDA, ISO, etc.) to execute responsibilities with minimal supervision.
  • Leverage comprehensive knowledge of system-level product development, including hardware, software, verification/validation, risk management, and integration testing.
  • Analyze quality and development data, generate reports, interpret trends, and make risk-based recommendations to support sound business and technical decisions.
  • Use expertise to streamline and enhance design assurance practices while avoiding unnecessary burden.
  • Represent the Quality organization on cross-functional Core Teams.
  • Review complex system solutions and verification results, clearly communicating findings to engineering teams to enable timely issue resolution.
  • Participate actively in design reviews and milestone reviews.
  • Operate effectively in both well-defined and ambiguous environments, applying sound judgment and risk-based thinking.


Qualifications:
  • Bachelor's degree in Engineering or a related technical field.
  • 8 years of experience supporting R&D development, with strong emphasis on design controls and regulated product development.
  • Experience supporting complex system integrations and cross-functional design teams is preferred


Knowledge and Skills:
  • Thorough understanding of risk management and design for manufacturability, serviceability, and reliability/
  • Attentiveness to details with strong organizational skills
  • Ability to work proactively and independently
  • Ability to multi-task and efficient in time management
  • Excellent verbal communication and interpersonal skills with the ability to work in a team environment


At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

Primary Work Location
USA NC - Durham - Roche Drive

Additional Locations

Work Shift

About Becton, Dickinson and Company

BD is a global technology company that provides diagnostics and technologies for frontliners. Through their solutions and services, they assist scientists in detecting diseases and advanced researchers' on developing diagnoses and therapeutics. BD was established in 1897 by Farleigh Dickinson and Maxwell Becton in East Rutherford, New Jersey.

Becton, Dickinson and Company Careers

Join the innovative world of Becton, Dickinson and Company (BD), a global medical technology company that is actively seeking driven, dedicated professionals to join our team. At BD, we are committed to advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. This commitment provides the foundation for a workplace where you can engage in meaningful work and where job opportunities abound.

Work You’ll Do

At BD, you will be part of a culture that values diversity, leadership, and innovation. Our team members are empowered to lead and inspire from day one. Join us and contribute to our mission of advancing the world of health through your professional skills and personal passion.

Transform Your Career

BD offers a unique position in the marketplace that combines industry expertise, leadership in medical innovation, and a collaborative culture to help you grow your career. Whether you are looking for an entry-level position or a more senior role, we provide the tools and support for your professional growth through comprehensive training and development programs.

Innovative Work Environment

Our team at BD is composed of more than 65,000 associates across the globe. These dedicated professionals work at the intersection of technology and healthcare, where they drive innovation and ensure that we stay ahead in a rapidly evolving industry. By joining BD, you will work alongside some of the brightest minds in the industry.

Internship and Employment Opportunities

Start your career with BD through our internship programs or dive straight into a full-time position. We offer a range of opportunities that allow you to explore different areas of our business and find a path that aligns with your career goals. Our hiring process is designed to be transparent and engaging, ensuring that all candidates—whether submitting a resume for an internship or a senior position—feel valued and informed.

Benefits and Culture

BD is proud to offer competitive benefits that support the health, well-being, and financial security of our employees and their families. From comprehensive health insurance to employee wellness programs and flexible working arrangements, we prioritize the well-being of our team members. Our inclusive culture encourages networking, continuous learning, and the sharing of ideas in a diverse and welcoming environment.

Join Our Team

Explore the job opportunities at BD and discover how your expertise can help shape the future of healthcare. Search open positions that match your skills and interests. We look for passionate, curious, creative, and solution-driven team players.

Stay Connected

Keep up to date with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. See what exciting and rewarding opportunities await at Becton, Dickinson and Company.

Explore Careers at BD

Whether you're preparing for your first interview or looking to advance into a leadership role, BD offers career paths that foster continuous growth and innovation. Join us in our mission to improve medical outcomes and enhance patient care worldwide.

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At Becton, Dickinson and Company, we are more than just a company; we are a community that is dedicated to making a difference in the lives of people all around the world.
Learn more about Becton, Dickinson and Company
Size
75,000 employees
Market Cap
$72 billion
Industry
Healthcare
Net Income
$1.6 billion
Founded
1897
5 Year Trend
+9.3%
Revenue
$18.2 billion
NASDAQ
BDX
* Ladders Estimates

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