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BD (Becton, Dickinson and Company) Staff Manufacturing Engineer – Site Validation Lead in San Jose, California

Job Description Summary

This is a role for an experienced validation engineer and a self-starter who will lead the site’s master validation schedule in both new product development and sustaining engineering environments.

Position is accountable for supporting new product development and product sustaining through the application of Quality and Validation engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and sustainment, and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and business unit policies, while meeting all design control and other regulatory requirements. This person facilitates validation activities for sustaining products, facilities, utilities, equipment and process. They will engage in discussions identifying, documenting and reporting quality issues to help resolve and maintain the site’s compliance and manufacturing ability. They will represent the site during external audits along with the regulatory and quality teams.

The position will report into the Operations team and work closely with project teams to encourage design-for-manufacturability within tight market windows of opportunities, while eliminating over-the-wall engineering.

BD Biosciences in San Jose, California manufactures flow cytometry medical instruments.

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:

  • Provide quality leadership to new product development teams in the areas of validation (IQ, OQ, PQ) and design transfer, risk management, and specification development of products, processes and tools.

  • Establish, coordinate and act as subject matter expert for the site's Master Validation Schedule; create, and maintain data for tracking validation activities, test results and validated systems

  • Responsible for reviewing qualification and validation protocols for products and components, facilities, utilities and equipment; resolves protocol discrepancies and deviations; supports change control

  • Guide engineers and projects teams in developing validation protocols

  • Drive product risk management activities and ensure quality and completeness of project design history files, validation packages, and change orders

  • Provide ongoing quality engineering support throughout the product life cycle. Provide support to development, engineering and manufacturing functions for validation planning and transfer activities. Assist teams in determining validation needs strategies and requirements. Ensure product development and validation programs meet requirements of FDA and ISO when applicable

  • Writes detailed Risk Assessments, conducts PFMEAs, and present analysis to management

  • Provide management with status updates on the validation master schedule, and escalate issues in a timely fashion

  • Support successful new product introductions and or sustaining product changes

  • Maintain a knowledge base of lessons learned to enable continuous improvement

  • Understanding of measurement uncertainties and measurement system analysis

  • Ability to effectively lead and influence cross functional teams

  • Strong problem identification and problem solving abilities

Required Qualifications:

  • Bachelor’s degree in Mechanical, Electrical, Reliability Engineering, or related.

  • Minimum 6 years’ experience in quality assurance field in a regulated environment

  • Minimum 5 years’ experience managing and executing process validations in the medical device industry

  • Knowledge of FDA CFR 21 Part 820 & EU 13485 Regulatory Requirements; CFR 21 Part 11 requirements for Electronic Records and Signatures.

  • Six-Sigma Green Belt

  • Quality Certification (e.g., CQE)

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 CA - San Jose

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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