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Associate Engineer - Stability

Apply Now Job ID R-334177 Date posted 03/28/2019

Job Description Summary

This position works closely with Engineers and Project Managers from R&D, Quality Engineering, and Regulatory Affairs to make strategic shelf life decisions for new products and changes to commercialized products. The position requires an understanding of medical device design control and domestic and international regulations pertaining to shelf life and expiration dating. This position will make shelf life assessments, draft/review protocols and reports, coordinate product aging, and provide evidence in support of product shelf life.

Job Description

ESSENTIAL DUTIES AND RESPONSIBILITIES including the following.  Other duties may be assigned.

  • Perform strategic stability assessments in support of changes to commercialized product and in support of new product development
  • Apply internal and external regulations pertaining to shelf life and expiration dating to BD UCC products
  • Knowledge and/or ability to learn Design Control and other QSR requirements
  • Design, review, plan, conduct and document laboratory experiments for the evaluation of new or improved products
  • Draft protocols, test reports, test methods and data summaries
  • Weekly maintenance of stability aging chambers, Preventative Maintenance and calibration of stability aging chambers and stability equipment
  • Performs tests and experiments in accordance with the requirements of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP)
  • Maintenance of stability databases
  • Stability project tracking and support
  • Compliance and continuous process improvement
  • Provide evidence of shelf life for products and packaging
  • Maintain compliance to annual requirements for combination products
  • Complete R&D department reports for Post Market Surveillance
  • Identification of OOT/OOS results, initiation of cross-functional reviews, completion of appropriate investigations

    QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/ or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Must be a self starter and work with minimal supervision.
  • Strong critical thinking skills and ability to review large quantities of data to make decisions.
  • Ability to organize the priority of work requirements and effectively work with team members to assign, communicate and meet realistic completion dates.
  • Proficient in the use of a personal computer with intermediate level of keyboarding skills.  Proficient in MS Word, Excel, and databases.
  • Strong organizational skills and ability to work in cross functional teams.
  • Strong interpersonal skills to include oral and written communication skills.
  • Ability to create, review and coordinate reports.
  • Ability to make and present engineering decisions.

EDUCATION and/or EXPERIENCE

  • Bachelor’s degree in technical field such as biomedical engineering, polymer science, chemistry, chemical engineering, mechanical engineering or other engineering field is required.
  • Knowledge and training in project management, QSR, process development, Electronic Databases and/or design control processes is a plus.
  • 0-2 years experience in consumer/medical product and process development.

LANGUAGE SKILLS

Ability to read, analyze, and interpret general technical procedures or government regulations.  Ability to write protocols, simple reports, and business correspondence.

MATHEMATICAL SKILLS

Ability to perform basic mathematical calculations. Working knowledge of statistics desired.

REASONING ABILITY

This position requires good judgment.  All product and process development activities within a team are to be carried out according to the applicable laws and regulations.  When in doubt, the incumbent should source out the appropriate information via internal and external resources.  In addition, should be able to analyze data and suggests additional courses of action.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is regularly required to sit, walk, talk or hear.  Specific vision abilities required by this job include close vision and color vision.  Some light lifting may be required.

WORK ENVIRONMENT

No special work environment conditions other than minimal exposure to manufacturing environment (i.e. noise, minimal heat and some chemical fume exposure) and laboratory settings.

Primary Work Location

USA GA - Covington BMD

Additional Locations

Work Shift

US BD 1st Shift 830am-5pm (United States of America)
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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