Job Description Summary

The Sr. 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 process to ensure products meet quality standards consistent with both Corporate and Unit policies, while meeting all design control and other regulatory requirements.

Job Description

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 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. 

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. 

Job Responsibilities

• Consistent application of technical principles, theories, concepts, techniques, and quality sciences/tools.

• Proven problem-solving skills.

• Makes measurable improvements to BD processes and procedures. Ensures that all design control and production/process control projects meet applicable regulatory (local and international), Corporate, and Unit requirements.

• Acts as a team member representing Quality on new product development and sustaining engineering projects.

• Reviews and has Quality Engineering approval authority for new and modified design/process specifications including product performance specification, test methods, etc.

• Assists with supplier and internal quality system audits as a means of evaluating the effectiveness of the established Quality System and good manufacturing practices (Auditor-in-training).

• May perform other duties as required.

Education and Experience

• Typically requires a minimum of a bachelor’s degree in science, engineering, or other relevant discipline and a minimum of 5 years relevant experience or a combination of equivalent education and 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.

• Applied knowledge of Corporate and/or Unit requirement.

• Able to contribute to the completion of specific programs and projects.

• Can ensure quality conduct of projects, including design, data summary and interpretation, and report generation for self and lower level project developers.

• Able to revise policies and procedures

• Able to make presentations

• 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 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

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 

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.  

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.  

To learn more about BD visit https://bd.com/careers

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.

Required Skills

Optional Skills

.

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift

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.

Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

Salary Range Information

106 600,00 $ - 175 900,00 $ USD Annual