Senior Quality Engineer

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

Reporting directly to the Associate Director of Quality, you'll be at the heart of our product development journey, applying your Quality Engineering expertise to both cutting-edge new products and essential product maintenance initiatives. This is your opportunity to make a real impact on patient safety and product excellence throughout the entire product lifecycle.

Responsibilities:

• Drive Quality Excellence: Apply advanced technical principles, quality sciences, and proven methodologies to ensure our medical devices exceed industry standards and regulatory expectations
• Solve Complex Challenges: Leverage your proven problem-solving skills to tackle quality issues head-on, creating measurable improvements to BD's processes and procedures that enhance efficiency and effectiveness
• Champion Regulatory Compliance: Ensure every design control and production/process control project meets all applicable local and international regulatory requirements, plus Corporate and Unit standards
• Collaborate Cross-Functionally: Serve as the Quality representative on dynamic new product development and sustaining engineering teams, bringing your expertise to multidisciplinary projects
• Exercise Approval Authority: Review and provide Quality Engineering approval for new and modified design/process specifications, including product performance specs, test methods, and critical documentation
• Develop Auditing Skills: Participate in supplier and internal quality system audits as an Auditor-in-training, evaluating the effectiveness of our Quality System and good manufacturing practices
• Lead Project Quality: Ensure quality conduct across projects—from design through data interpretation and report generation—for both your work and that of junior team members
• Shape Our Future: Contribute to specific programs and projects that advance our quality capabilities, and prepare/revise policies and procedures that guide our organization
• Own The Journey: Manage projects and tasks from product inception through launch and ongoing maintenance, ensuring products consistently meet quality standards at every stage

Required Qualifications:

• Bachelor's degree in Engineering and 5 years relevant experience OR
• Master's degree in Engineering and 3 years relevant experience.

Knowledge and Skills:

• Applied knowledge of the FDA medical device quality system regulations and international quality system standards/regulations (e.g. - 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, EU MDR/IVDR) as it relates to the design and continued support of BD products.
• Can ensure quality conduct of projects, including design, data summary and interpretation, and report generation for self and lower level project developers.
• Can independently determine and develop approach to solutions.
• Able to provide guidance and work direction to lower level project developers.
• Can design and perform development working independently within defined parameters with minimal supervision required.
• Experience with BD software systems utilized in the Quality Systems is desirable.
• Must have knowledge/specialization in one or more of the following areas:
• Acceptance sampling theory and application
• Statistical process control methods and application
• Measurement system/test method knowledge and analysis
• Quality planning
• Failure analysis investigation
• Design of Experiments
• Process mapping and value stream analysis
• Hypothesis testing
• Descriptive statistics
• Process capability analysis
• Basic quality tools: Pareto, box plots, histograms, scatter diagrams, etc.
• Risk Management
• Supplier quality management
• Auditing
• Design/development tools
• Process validation
• Software validation

At BD, We Prioritize On-Site Collaboration

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.

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 insurance
• Long-term care with life insurance

Other Well-being Resources

• Anxiety management program
• Wellness incentives
• Sleep improvement program
• Diabetes management program
• Virtual physical therapy
• Emotional/mental health support programs
• Weight management programs
• Gastrointestinal health program
• Substance use management program
• Musculoskeletal surgery, cancer treatment, and bariatric surgery benefit

Retirement and Financial Well-being

• BD 401(k) Plan
• BD Deferred Compensation and Restoration Plan
• 529 College Savings Plan
• Financial counseling
• Baxter Credit Union (BCU)
• Daily Pay
• College financial aid and application guidance

Life Balance Programs

• Paid time off (PTO), including all required State leaves
• Educational assistance/tuition reimbursement
• MetLife Legal Plan
• Group auto and home insurance
• Pet insurance
• Commuter benefits
• Discounts on products and services
• Academic Achievement Scholarship
• Service Recognition Awards
• Employer matching donation
• Workplace accommodations

Other Life Balance Programs

• Adoption assistance
• Backup day care and eldercare
• Support for neurodivergent adults, children, and caregivers
• Caregiving assistance for elderly and special needs individuals
• Employee Assistance Program (EAP)
• Paid Parental Leave
• Support for fertility, birthing, postpartum, and age-related hormonal changes

Leave Programs

• Bereavement leaves
• Military leave
• Personal leave
• Family and Medical Leave (FML)
• Jury and Witness Duty Leave

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.

Salary Range for Franklin Lakes, NJ: $ 110,200.00 - 176,400.00 USD Annual