BD (Becton, Dickinson and Company) R&D Technician II in New Hope, Minnesota
Primary focus of this position is to assist the R&D engineers in developing, optimizing and validating drug-coating processes of a medical device. The incumbent will perform tests, collect data, record results and analyze data; build parts for engineering evaluation, pre-clinical and clinical studies, and commercial sales; assist engineer for preparation of work instructions and standard operating procedures; assist engineer in executing validation; support equipment development; support other activities from R&D, Quality, Operations and Regulatory Affairs.
With minimal supervision, perform tests by following instructions from development engineer; collect data and record test results; analyze test data when it is necessary.
Maintain accurate data and organize and present data in a reportable format.
Prepare coating solutions, set-up equipment and perform coating and assembly tests.
Coordinate product builds and build parts for engineering evaluation, pre-clinical and clinical studies, and commercial sales.
Assist development engineer in preparation of work instructions and test methods.
Perform equipment calibration and preventative maintenance.
Conduct process development activities with minimal supervision to determine key process inputs and output, and establish relationship between inputs and outputs.
Provide process/test method training to manufacturing/QA personnel.
Prepare test data. Assist engineer in analyzing data.
Assist in new process equipment development; develop specifications, work instructions, preventive maintenance, and calibration procedures.
Assist in system assurance including documentation, testing and inspection, product and process development, and non-conforming product investigations. Assist in the support of Manufacturing, R&D and Regulatory to ensure systems are in compliance with all internal and external guidelines.
Experience in drug coating, active pharmaceutical ingredient handling, and working in controlled environment.
Experience in process validation (IQ, OQ and PQ); ability to assist in executing validation.
Knowledge of basic statistics and knowledge of GMP and GLP are preferred.
Basic computer skills (MS Windows, MS Outlook, Word, Excel and PowerPoint)
Education: High school diploma or equivalent experience. Associates degree or higher preferred.
Experience: Minimum 4 years of industrial experience in R&D or process development, or Associates degree in science, math or engineering with two years related experience preferably in medical device or other regulated FDA/QSR and ISO environment.
Ability to follow instructions, collect data and record test results.
While performing the duties of this job, the employee may be required to stand, walk, sit and use hands to manipulate tools, controls and office equipment. Work may involve continuous computer use with repetitive motion to wrists, hands and fingers. The employee frequently is required to see, talk and hear. The employee is occasionally required to bend, lift, reach or stoop. Inability to meet one or more of these physical demands will not automatically disqualify a candidate or employee from the position. Upon request, the company may make reasonable accommodations.
While performing the duties of this job, the employee may be in an open cubicle environment. Employee 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.
Industry Standard/Category: R&D Technician II
Career Level: experienced
Division Name: New Hope, MN / Lutonix
Relocation: Relocation Not Available
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.