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BD (Becton, Dickinson and Company) Senior Quality Engineer, Software in Louisville, Colorado

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 Senior Quality Engineer, Software is responsible for ensuring products are developed and released meeting customer expectation, regulatory requirements, appropriate voluntary standards, and BD policies and procedures. This position will work as a member of cross-functional project teams engaged in ongoing Product Life Cycle technical support. Will serve as a quality representative on project 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.

Essential duties and responsibilities:

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

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

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

  • Leadership in failure investigations, corrective and preventive actions plan and continuous improvement projects.

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

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

  • Drives Reliability planning and Quality Planning for New Product Development.

  • Other duties as assigned

Qualifications:

  • Extensive 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 Medical Devices and Disposables including design transfer to manufacturing, experience should include Risk Management and Reliability Engineering

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

  • Expertise in Design Verification, Design Validation Process, Test Method and Software Validation for Medical Devices

  • Ability to participate and provide leadership on teams and maintain positive work environment with those teams. Understands team functions, leadership technique, time management, project management methodologies and able to balance multiple task assignments

  • Excellent communication skills (verbal, written, and presentation). Understands how to present information dependent upon the level of the audience.

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 81,300.00 - 134,100.00 USD 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).

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 https://jobs.bd.com/

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

Work Shift

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.

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.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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