BD (Becton, Dickinson and Company) R&D Engineer II in New Hope, Minnesota
Category: R&D Engineer
Job ID: 2018-11633
Career Level: experienced
Division: New Hope, MN/Lutonix
Location: New Hope,Minnesota,United States
Summary of Position with General Responsibilities:
The indiviual in this role will develop, optimize, and validate drug coated balloon manufacturing processes. The candidate will conduct process development activities to understand process inputs, outputs and relationship of inputs and outputs. The candidate will perform hands-on testing in optimization of coating formulations, coating processes, balloon folding processes, and product drug release. The candidate will write process validation protocols/reports, prepare work instructions and standard operating procedures, conduct process qualification and validation, support equipment development, and support other activities from R&D, Quality, Operations, and Regulatory Affairs.
Essential job Functions:
Develop and optimize manual and automated manufacturing processes.
Perform lab bench testing and pre-clinical testing to characterize process output(s).
Set-up manufacturing and/or test equipment and perform process and product tests.
Investigate the effect of process inputs on both quality and yield.
Conduct process development activities and compose technical reports
Determine key process inputs and outputs of manufacturing processes including solution preparation, balloon coating, and balloon folding.
Establish correlation between process inputs and process outputs using statistical methods (such as DOE) and/or oversee test execution with minimal supervision.
Prepare work instructions and standard operating procedures.
Build test parts for engineering evaluation and pre-clinical studies.
Prepare process validation protocols/reports and oversee in execution of validation building/testing.
Support new equipment development, including specification development, vendor selection, and negotiation.
Generate and communicate project strategies and scenario plans to management.
Additional Desirable Qualifications Skills and Knowledge:
Experience with balloon catheters, stents and stent delivery systems preferred.
Experience leading small cross-function process development teams.
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 problem solving skills and hands-on technical aptitude
Excellent oral and written communication skills
Knowledge of cGMP and GLP is a plus.
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