Sr. Design Quality Engineer

Becton Dickinson; United States; On-site; USD 95,000 - 140,000; Full time

Benefits offered by this job

Annual Bonus

Discretionary LTI Bonus

Health and Welfare Benefits

Life and AD&D Insurance

Short-/Long-term Disability

Job summary

Becton Dickinson is seeking a Quality Engineering leader to drive design controls, risk management, validation, and supplier quality across global programs. You will partner with cross-functional teams to ensure robust product release and compliance with regulatory requirements.

The role emphasizes continuous improvement, data-driven decisions, and collaboration with R&D, Manufacturing, and Quality Operations to deliver high-quality medical devices.

Qualifications

• Requires a degree in a relevant field with 5+ years of experience or a master's degree with 3+ years of experience.
• Experience driving design controls, risk management, validation, and supplier quality in medical devices.
• Demonstrated ability to lead audits, change control, and product release activities.

Responsibilities

• Plan and lead Quality Engineering efforts across R&D and Worldwide Operations.
• Ensure design control requirements are followed throughout product development.
• Lead risk management activities and mitigate project risks.
• Ensure compliance with global quality standards and regulatory requirements.
• Support product release activities for developing products.
• Provide guidance during audits and regulatory interactions.
• Develop robust validation plans for products and processes.
• Define supplier qualification and global control strategies.
• Establish robust incoming inspection methods and test criteria.
• Lead investigations and root cause analysis for nonconforming products.

Skills

Design Controls

Risk Management

Validation

Supplier Quality

Product Release

Audits

Change Control

Data Analysis

Cross-functional Collaboration

Education

Bachelor's Degree in relevant field

Master's Degree in relevant field

Job description

We are the people who give possibilities purpose

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.

Job Description

This role drives design controls, risk management, validation, supplier quality, and product release activities while partnering closely with cross-functional teams to deliver high-quality products and processes. The successful candidate will serve as a trusted quality advisor, proactively solve complex quality challenges, and champion continuous improvement initiatives that enhance product quality and customer experience.

Responsibilities

• Plan and lead Quality Engineering efforts supporting R&D and Worldwide Operations initiatives.
• Evaluate customer requirements and applicable quality standards to ensure project compliance.
• Ensure all design control requirements are effectively executed throughout product development.
• Lead product risk management activities and proactively identify, assess, and mitigate project risks.
• Ensure compliance with global product stewardship procedures, quality standards, and regulatory requirements.
• Support product release activities for products under development.
• Provide Quality Engineering guidance during audits, customer inquiries, and regulatory interactions.
• Establish and oversee worldwide validation plans for product and process designs.
• Ensure process validation activities are completed and meet quality requirements.
• Ensure supplier qualification plans affecting product design are defined and executed.
• Define and maintain global product and process control strategies.
• Establish robust incoming inspection processes, including: Test method development, Inspection criteria definition, Equipment qualification and Sustainable inspection practices
• Ensure test methods are validated and equivalent across manufacturing sites and suppliers when applicable.
• Initiate change control submissions and collaborate with R&D and Engineering to provide quality assessments.
• Review and approve new or revised product and process specifications, including: Product performance specifications, Test methods, Process validation documentation, and Quality-related technical documentation
• Lead or support failure investigations and root cause analysis for nonconforming products.
• Develop practical and innovative solutions to quality and product challenges.
• Ensure quality-focused project execution, including data analysis, interpretation, and reporting.
• Partner closely with Quality Operations, Integrated Supply Chain (ISC), Global Industrial Engineering (GIE), R&D, Engineering, and other cross-functional teams.
• Serve as a trusted Quality Engineering advisor across the organization.
• Provide guidance and technical direction to junior Quality Engineers when applicable.
• Actively pursue professional development and share knowledge across teams.
• Promote continuous improvement initiatives that enhance product quality, operational effectiveness, and customer experience.
• Ensure lessons learned are captured, communicated, and leveraged across future projects.

Required Qualifications

• Bachelor's Degree in relevant field and 5 years relevant experience OR
• Master's Degree in relevant field and 3 years relevant experience

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.

For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

At BD, we are committed to supporting our associates' well-being, development, and success through a performance-based culture.

For this position, BD offers a competitive compensation package along with the following benefits specific to this role:

• Annual Bonus
• Potential Discretionary LTI Bonus

Health and Well-being Benefits

• Medical coverage
• Health Savings Accounts
• Flexible Spending Accounts
• Dental coverage
• Vision coverage
• Hospital Care Insurance
• Critical Illness Insurance
• Accidental Injury Insurance
• Life and AD&D insurance
• Short-term disability coverage
• Long-term disability