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BD (Becton, Dickinson and Company) R&D Engineer II in Tempe, Arizona

Job Description Summary

Job Description

Primary focus of this position is to support R&D efforts needed to support new and existing combination medical device products. Candidate will work cross functionally on projects and will be responsible drafting and executing change orders needed to support the projects in a timely manner; prepare work instructions and standard operating procedures; conduct process qualification and validation; support equipment development; support other activities from R&D, Quality, Operations and Regulatory Affairs.

Responsibilities:

  • Support engineers on new and existing projects.

  • Conduct change request to make updates to processes, prints, labels, artwork, etc.

  • Prepare work instructions and standard operating procedures.

  • Prepare process validation protocols, execute validation, and write validation reports.

  • Support new process equipment development, including specification development, vendor selection, and negotiation.

Qualifications:

  • Education: B.S. degree in Biomedical Engineering, Chemical Engineering or other related engineering discipline.

  • Experience: 1-3 years of industrial experience in R&D or process development, preferably in medical device or other regulated FDA/QSR and ISO environment.

Preferred Qualifications:

  • Experience with change orders in Master Control documentation system

  • Experience with balloon catheters, stents and stent delivery systems preferred.

  • Experience in process validation (IQ, OQ and PQ), including writing protocols and reports to support verification and validation activities for product commercialization.

  • Experience in drug coating, active pharmaceutical ingredient handling, and working in controlled environment.

  • Training in Six Sigma or Design for Six Sigma. Ability to analyze data, interpret results and write reports. Proficient in statistic software, such as MiniTab, is a plus.

  • Demonstrated hands-on technical aptitude

  • Excellent oral and written communication skills

  • Knowledge of cGMP and GLP is a plus.

Physical Demands:

While performing the duties of this job, the employee may be required to stand, walk, sit and use hands to manipulate tools, controls and office equipment. Work may involve continuous computer use with repetitive motion to wrists, hands and fingers. The employee frequently is required to see, talk and hear. The employee is occasionally required to bend, lift, reach or stoop. Inability to meet one or more of these physical demands will not automatically disqualify a candidate or employee from the position. Upon request, the company may make reasonable accommodations.

Work Environment:

While performing the duties of this job, the employee may be in an open cubicle environment. Employee must be able to work in a team-oriented, fast-paced environment.

This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.

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 LocationUSA AZ - Tempe Headquarters

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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