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Job Information

BD (Becton, Dickinson and Company) Advanced Quality Engineer I in Warwick, Rhode Island

Job Description Summary

To assure that new product designs and the processes for manufacturing them meet all Corporate and Divisional requirements with respect to safety and efficacy. Be an active team member and cross-function collaborator on new product development and product enhancement project teams for implantable medical devices. Be an active team member for investigating quality complaints, examining non-conformances and executing CAPAs. The scope of the work is across all phases of development activity, including vendors and suppliers. The work has an impact on product function, product release dates, product quality, and product costs.

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.

Essential job Functions

Product Development:

  • Provide Technical mentorship to Quality Engineers, Quality Technicians, and Inspectors.

  • Development of Test Protocols and Final Report to support Regulatory 510K, PMA, CE mark and International registrations.

  • Support Pre-Concept Front End Product Innovation Process activities for new technologies.

  • Lead Quality Engineering Projects to improve Quality systems and Procedures.

  • Creation of the DFMEA, coordinating guidance from the other Design Sub-team members.

  • Developing Final Design Verification Protocol and the subsequent report including an analysis of all data and a decision on design acceptability.

  • Provide recommendations into the project Design Input Summary (DIS), Product Performance Specification (PPS), Product Development Plan (PDP), and applicable design control documents as defined per Davol’s product development process.

  • Resolve the degree of Biocompatibility testing required as per ISO10993 and company procedures. Co-ordinate the testing at an outside lab and document results.

  • Develop or assist in development of inspection and test methods per product specifications.

  • Develop test protocols and release a final report on Shelf Life and Stability Studies in support of expiration dating.

  • Perform test method validations to ensure accuracy, precision, selectivity, sensitivity, stability, and reproducibility of analytical or physical test methods used to assess the safety and efficacy of devices.

  • Develop shelf life and stability test protocols and reports as required.

Process Development:

  • Develop and detail the Control System for the manufacture of new products including Inspection Plans for the inspection of components, sub-assemblies and final product.

  • Support the creation of manufacturing control plans for internal and outsourced processes.

  • Support (or lead) development of the PFMEA and craft and qualify inspection test methods and equipment..

  • Perform and/or support Process Development Studies to determine the acceptability of new processes or equipment.

  • Provide Quality Engineering Support to outsourced analytical laboratories and manufacturing facilities to ensure compliance with applicable requirements of 21CFR 820, 210, 211; cGMP’s, and ISO13485:2003 requirements.

  • Lead supplier part qualification activities including mold qualification and DOEs.

  • Support Process Transfers to the Production facilities.

Other:

  • Make dispositions of rejected nonconforming components and products; conduct MRB action when required.

  • Organize and generate detailed quality information reports to show trends and the impact of process improvements.

  • Conduct other Quality Control Projects as assigned by the Manager of Advanced Quality Engineering.

  • Support the development and effective implementation of Corrective and Preventive Action Plans to resolve quality non-conformances.

  • Perform DOE’s and other statistical analysis to support product and process optimization or determine causes of process variation. Initiate corrective actions as required.

  • Provide technical support to resolve quality problems in development, pilot, manufacturing or with suppliers as warranted.

  • Support goals of the Quality Assurance Department.

Basic Qualifications:

  • B.S. or M.S. in Mechanical Engineering, Biomedical Engineering, Technical science, or equivalent combination of Bachelors Degree and related work experience.

  • With B.S., minimum of 2 years experience or M.S. with minimum of 1 year experience in Quality Engineering including design controls, product/process validation, risk management, and technical problem solving

  • A high level of competence in Quality Technology, statistical techniques, and six sigma tools including: sampling plans, process capability analysis, gage R&R, hypothesis testing, analysis of variance, regression, and design of experiments.

  • Strong Design Control understanding from concept to launch; especially in post-market activities (including complaints, failure investigations, and CAPAs).

  • Applied Knowledge of the requirements of FDA QSR, ISO13485and ISO 9001.

  • Good oral and written communication skills; travel flexible.

  • Ability to work with and empower people.

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.

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Primary Work Location

USA RI - Warwick

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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