Becton, Dickinson and Company

Senior Quality Engineer - Product Development

Becton, Dickinson and Company • $95K — $115K *
Tempe, AZ 85281In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • BS in Engineering
  • 5+ years in engineering or Quality engineering in medical devices or pharmaceuticals
  • Experience with combination products preferred
  • Quality Engineering Certification (ASQ) is a plus
  • Strong understanding of regulatory compliance (ISO 13485, ISO 14971, 21 CFR)

Responsibilities

  • Lead development of risk assessments and test methods
  • Conduct component qualifications and validation processes
  • Manage product investigations and assess design changes
  • Support manufacturing control plan translations from design inputs
  • Represent quality engineering on product development and design review teams
  • Prepare and present project updates and technical discussions
  • Support audits and assist in writing technical submissions

Benefits

  • Opportunity to work on innovative combination products
  • Engagement in cross-functional team leadership
  • Exposure to regulatory compliance and quality standards
  • Professional development opportunities
  • Flexible travel for project-related needs
Full Job Description
Job Summary:

This position supports product leadership and risk management of new product development and sustaining activities for combination products. The role may include aspects of manufacturability, scalability, manufacturing transfer and post launch sustainability of combination products.

This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.

Job Responsibilities:
  • Technical leadership skills including an understanding of medical device operations (e.g., medical device manufacturing, process development, quality assurance)
  • Leads development of risk assessments and test methods
  • Leads component qualifications, design validation / verification and process validation
  • Leads product investigations
  • Ability to make and present risked based decisions
  • Assess product changes against product design
  • Supports translation of design inputs into manufacturing control plans
  • Develop and implement procedures to comply with corporate and industry standards.
  • Coordinates and/or directs all aspects of product development activity related to a product line
  • Quality engineering representation on Product Development Teams to design, develop, and implement new products and processes for a medical device, translating intangible design inputs into tangible engineering specifications and test plans
  • Quality engineering representation on Design Review Teams
  • Prepare and present project updates and technical discussions
  • Participate in project planning, budgeting, scheduling, and tracking
  • Support internal and external supplier audits
  • Provide support to the regulatory department in writing technical submissions
  • Comply with company procedures and policies, government regulations
  • Ability to travel for business, project, and issues approximately up to 25% of time.
  • Other duties and projects, as assigned


Education and Experience:
  • BS in Engineering
  • Minimum of five years' experience in engineering or Quality engineering experience within the medical device, pharmaceutical, or equivalent industry
  • Pharmaceutical or combination product experience preferred


Knowledge and Skills:
  • Knows how products are used and impact the user(s) so that risk can be managed effectively
  • Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.)
  • Ability to lead creation of risk management files
  • Ability to develop solutions with business impact
  • Advanced statistical and risk assessment techniques
  • Working knowledge of test method (development and validation), equipment qualifications, process and design validation, risk assessment techniques, and component qualification methodologies
  • Ability to make and present risk-based decisions
  • Strong interpersonal skills
  • Ability to analyze and optimize manufacturing and quality systems Product, design & prototyping
  • Ability to create and provide trainin
  • Problem solving ability
  • Ability to create, review and coordinate test protocols and reports
  • Ability to generate engineering proposals
  • Oral and written presentation skills
  • Ability to Lead cross functional teams
  • Understanding of regulatory requirements including ISO 13485, ISO 14971, 21 CFR 210/211/820
  • Preferred Qualifications:
  • Quality Engineering Certification (ASQ) or equivalent


Primary Work Location
USA AZ - Tempe Headquarters

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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