Seeking Process Development Engineer
We are seeking a Process Development Engineer to join the R&D department of a Plymouth, MN medical device company.
Primary focus of this position is to 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 to optimize 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.
Education: B.S. degree in Biomedical Engineering, Chemical Engineering or related engineering discipline.
Experience: Minimum of 4 years of 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 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.
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. Our client 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.
HOW TO APPLY: Send your resume to info @ tayleestaffing [dot] comApply Now!
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