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Job Information

BD (Becton, Dickinson and Company) Staff Quality Engineer Software in Franklin Lakes, New Jersey

Job Description Summary

The Diabetes Care business unit has a long history within BD and is unique in that it focuses on one important disease state which is a threat to world health. Within the Diabetes Care business, you will have the opportunity to develop exciting new products and provide key contributions to BD's future growth.

The Staff Software Quality Engineer will work as a member of a cross-functional project team engaged in the design and development of new Medical devices. This individual will be responsible for providing quality leadership, guidance and support in software design control methodologies for software driven medical devices. The candidate will work directly with the product development team in support of the development of key diabetes treatment devices. The position requires the ability to handle multiple tasks utilizing a high level of written and oral communication skills.

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.

Responsibilities

This individual will be responsible for providing quality leadership, guidance and support in quality system methodologies for medical device software development and manufacturing. This candidate will work directly with product development teams in support of the development and manufacturing of medical device products with software. The position requires the ability to handle multiple projects and tasks utilizing a high level of written and oral communication skills. In this position, the candidate will be responsible for Software Quality Assurance activities by:

  • Participating or leading in medical device software design and development planning; quality planning; supporting development of software design requirements specification, software design and architecture activities; Design History File management, software design transfer activities, software change management and software design reviews;

  • Developing software risk management documentation;

  • Supporting development of software design verification and software design validation documentation;

  • Supporting software test method development and validations;

  • Supporting software tool development and validations;

  • Ensures BD Diabetes Care policies, procedures, practices and facilities are in compliance with all applicable corporate regulatory policies;

  • Lead/support internal investigations, implementing corrective and preventive actions;

  • Serving as a quality representative on one or more project teams engaged in software product development activities for medical devices;

  • Ensuring each project is developed and released meeting customer expectations, regulatory requirements including 21CFR820, ISO 13485, ISO 14971, MDD 93/42/EEC, IEC 62304, IEC 82304 and FDA Software Guidance documents.

Requirements

  • BS degree in engineering or technical sciences. MS preferred.

  • A minimum of 12 years relevant experience or a combination of equivalent education and relevant experience.

Employment at BD is contingent upon the Company’s receipt of sufficient proof that you are or will be fully vaccinated against COVID-19. 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 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 NJ - Franklin Lakes

Additional Locations

USA MA - Andover

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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