BD (Becton, Dickinson and Company) R&D Engineer in New Hope, Minnesota

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.

Position Overview

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.

  • 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.

  • 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

#LI-OPS

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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

ID: 2018-12357

Career Level: entry level

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.