Job Description Summary

As directed by the Quality Manager, 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 processes 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. 

Duties and Responsibilities:

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

• 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

• Is 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 specifications, test methods, etc.

• Contributes to the completion of specific programs and projects

• Ensures quality conduct of projects, including design, data summary and interpretation and report generation for self and developers

• Independently determines and develops approach to solution

• May provide guidance and work direction to other team members

• Designs and performs development working independently within defined parameters with minimal supervision required

• Support of the following, however are not limited to:

Design Control:

• Design Input

• Design Output

• Design Verification plans, protocols, and reports

• Design Validation

• Design Reviews

• Design History File support

Change control:

• Assessment of Change Request (ACR) Responses

• Risk Management

• Process Validations

• Identification of CTQ's

• Unit Quality Independent Reviewer During Design Reviews

• Handling of deviations and non-conformances

• Test method validations

• Supplier qualification

• Software validations

• Post Market Surveillance

• Situation Analysis

• CAPA – Root cause investigation and implementation of corrective / preventive actions

• Proper Use of Statistics (Sampling Plans)

• Advise on Regulations

• Liaise with Manufacturing Plants

• Provide functional support to cross-functional teams

• Internal and external audits

Qualifications:

• Bachelor’s Degree in Mechanical, Electrical, Biomedical or similar or equivalent experience in medical device industry.

• 3-5 years relevant experience or a combination of equivalent education with a medical device company delivering electromechanical software driven instruments or devices.

• Experience in working in quality systems compliant with 21CFR, ISO 13485/14971 and IEC 62304 preferred.

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.

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/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status. 

Required Skills

Optional Skills

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Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift