Bard Access Systems New Hope , MN 55428
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.
Primary focus of this position is to assist in developing, optimizing and validating a drug coating process of a medical device. The candidate will perform hands-on testing in optimization of coating formulations, coating process and product drug release; conduct process development activities to understand process inputs, outputs and relationship of inputs and outputs; assist in writing process validation protocols and reports; prepare work instructions and standard operating procedures; assist in conducting process qualification and validation; support equipment development; support other activities from R&D, Quality, Operations, and Regulatory Affairs.
Summary of Position with General Responsibilities
Assist in developing and optimizing coating formulations and coating process.
Perform lab bench testing and pre-clinical testing to study drug releasing.
Prepare coating solutions, set-up equipment and perform coating and assembly tests.
Collaborate to investigate key factors that affect drug release, coating quality and yield.
Write technical reports.
Conduct process development activities to understand key process inputs and outputs in coating solution preparation, drug coating and balloon folding processes; establish correlation between process inputs and process outputs using statistic methods, such as DOE.
Prepare work instructions and standard operating procedures.
Build test parts for engineering evaluation, pre-clinical studies and clinical studies.
Assist in preparing process validation protocols, executing validation, and writing validation reports.
Support new process equipment development, including specification development, vendor selection, and negotiation.
B.S. degree in Biomedical Engineering, Chemical Engineering or other related engineering discipline, or equivalent experience.
0-2 years of industrial experience in R&D or process development, preferably in medical device or other regulated FDA/QSR and ISO environment.
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 preferred.
Experience in drug coating, active pharmaceutical ingredient handling, and working in controlled environment preferred.
Demonstrated hands-on technical aptitude
Ability to analyze data, interpret results, and write reports. Proficient in statistic software is a plus.
Excellent oral and written communication skills
Knowledge of cGMP and GLP is a plus.
Training in Six Sigma or Design for Six Sigma preferred
While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment. The employee frequently is required to talk and hear. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.
While performing the duties of this job, the employee may be in an open cubicle environment. Candidate 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.