BD (Becton, Dickinson and Company) R&D Engineer II in New Hope, Minnesota
Job ID: 2018-11633
Career Level: experienced
Division: New Hope, MN/Lutonix
Location: New Hope,Minnesota,United States
Trailblazing Innovation for Patients
BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We lead in patient and healthcare worker safety, and technologies that enable medical research and clinical laboratories. Our innovative solutions help advance medical research and genomics, enhance the diagnosis of infectious disease and cancer, improve medication management, promote infection prevention, equip surgical and interventional procedures, optimize respiratory care and support the management of diabetes.
Our Minneapolis location, Lutonix, is a design center focused on the advancement and continuous success of Lutonix Drug Coated Balloon, one of BD’s prized Peripheral Intervention products. Our culture is a natural home for driven, strategic and proactive people who want to follow our motto of Trailblazing Innovation for Patients. Lutonix utilizes collaborative, cross functional teams that operate globally; our team is committed to making a difference in patients’ lives around the world. This is a place you can find a career with meaningful purpose – advancing the world of health through your successes.
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.
B.S. degree in Biomedical Engineering, Mechanical Engineering or related engineering discipline.
4 or more years of engineering experience
2 or more years of experience in R&D or process development
2 or more years of medical device experience preferred
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