Job ID R-418331 Date posted 11/10/2021

Be part of something bigger at BD. Here, you’ll join a driven, agile engineering team working in a startup-like environment that has the backing and resources of a Fortune 500 company. In engineering, you could be involved in everything from operations, production and construction to information technology and maintenance environments, all while analyzing and developing solutions to further our engineering capabilities. You’ll use your talent and track record of solving complex problems to achieve one singular goal: advancing the world of health™. At BD, you can make a true difference of one.

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Job Description Summary

Job Description

Be part of something bigger!

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

The Quality Engineer II is responsible for ensuring TTM products are developed and released meeting customer expectation, regulatory requirements, appropriate standards, and BD policies and procedures. This position will work as a member of a TTM cross-functional project team engaged in ongoing Product Life Cycle technical support. Will serve as a quality representative on project core teams and will work closely with R&D, Operations, Regulatory Affairs, Marketing and Distribution. This position requires a self-directed individual able to prioritize different projects and tasks utilizing a high level of written and oral communication skills. In addition, the incumbent may be expected to initiate quality initiative projects, become thoroughly knowledgeable with all aspects of Sustaining Engineering and/or New Product Development projects, and assume personal responsibility for the successful completion of all tasks within the realm of Quality Engineering responsibilities.

Duties and Responsibilities:

  • Participates on Project Team as Quality Representative. Ensures that principals of Design Control are applied to Product and Process Changes and New Product Development.

  • Lead Quality Initiatives for Target Temperature Management products that include the entire product life cycle (Development, Commercialization and Post Market Surveillance).

  • Creates, reviews, and approves Risk Management File documents such as: Risk Management Report, Hazard Analysis, Risk Benefit Analysis and FMEA’s

  • Creates Design Specifications, Design Verification Protocols and reports, Process and Product Validations, Software Validation documents and Test Method Validations

  • Leadership in failure investigations, corrective and preventive actions plan and continuous improvement projects using methodologies as Six Sigma/Lean Six Sigma.

  • Creates, reviews and improves Quality System Documents (CAPA, Audits, Risk Management, Design controls).

  • Creates and reviews Product Documents.

  • Participates in Internal, External and Supplier Quality Audits.


Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Knowledge of Medical Device standards and regulations including ISO 13485, ISO 14971, FDA regulations QSR, IEC 60601-1 including particular and collateral standards, IEC 62304 Medical device software life cycle and IEC 62366 Usability.

  • Experience in Design controls for electromechanical Devices and disposables, including Risk Management, Design Verification, Design Validation, Test Method Validation.

  • Knowledge of manufacturing processes.

  • Ability to understand Medical Devices Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency.

  • Understands applied statistics concepts for Quality and Reliability, statistical sampling plans, statistical process control and advanced statistical methodologies such as DOE.

Education and Experience:

  • B.S. in Engineering, Engineering Technology, Science a minimum.

  • Minimum 3 years of proven ability with FDA regulated industry, preferably on product development programs

  • American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.) preferred

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”. The anticipated compensation range for this position is $75,000 - $80,000USD Annual and the compensation offered will depend on the candidate’s qualifications.

*BD follows the Pay Transparency and non-discrimination provisions described by the Colorado Department of Labor and Employment (CDLE).

For most roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In limited circumstances, weekly testing for COVID-19 may be available instead of vaccination. 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 empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.

You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.

To learn more about BD visit

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.


Primary Work Location

USA CO - Louisville

Additional Locations

USA PA - Zelienople

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Advancing the world of health™

BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.

As a new employee what I like most about BD are the many learning and professional developmental opportunities for growth offered. It is good to know that there are so many resources to choose from.

Zakiyyah Walker
Staff Engineer

Since joining BD, I really have liked the people I work with on a daily basis and the collaboration towards common goals.

Michael Carrano
Senior Program Manager

BD is full of passionate, loyal, and driven people that have a common goal of advancing healthcare without sacrificing quality or service.

Justyna Zielinska
Project Manager



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