BD (Becton, Dickinson and Company) R&D Engineer II in New Hope, Minnesota
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.
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.
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.
- 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
While performing the duties of this job, the employee may be required to stand, walk, sit, wear personal protective equipment, and use hands to manipulate tools, controls and office equipment. Work may involve continuous computer use with repetitive motion to wrists, hands and fingers. In addition, the employee must have visual acuity and color perception to conduct clean-room and laboratory duties. Inability to meet one or more of these physical demands will not automatically disqualify a candidate or employee from the position.
While performing the duties of this job, the employee may work with chemicals and/or biological materials. The employee may be in an open cubicle environment and must be able to work in a team-oriented, fast paced environment. Bard Lutonix is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.
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.
Industry Standard/Category: R&D Engineer
Career Level: experienced
Division Name: New Hope, MN/Lutonix
Relocation Available?: No
External Company Name: C.R. Bard, Inc.
External Company URL: www.crbard.com
C. R. Bard, Inc. (NYSE: BCR) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 13,000 people around the world. Founded in 1907, we pioneered many devices that are now the cornerstones of modern healthcare.
We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded. Bard is a M/F, Disabled and Vet EEO/AA Employer.
Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world.