The primary focus of this position is to work cross functionally to complete product design and development activates for a combination balloon catheter device in a fast-paced startup medical device company. Additionally, this position will facilitate transfer to manufacturing activities, process development, manufacturing scale-up, and ensure device manufacturing is conducted efficiently according to the company quality system. The position focuses on balloon catheter manufacturing, drug coating processing, project planning, test method development, process validation, design verification & validation, analysis and reporting.
• Write protocols and reports to support process and equipment validation (IQ, OQ and PQ)
• Establish correlation between process inputs and process outputs using statistical methods (such as DOE)
• Create plan/report and execute process validation
• Develop and update all applicable manufacturing documents including MPs, IPs, LHRs, and material handling procedures.
• Participate and create in risk management documentation including DFMEA, PFMEA, UFMEA, and risk management plan/report
• Develop and refine product test methods and complete test method validation.
• Complete Protocol/Report for design verification
• Initiate and assist in the investigation and disposition of nonconforming materials.
• Develop strategies/plan to ensure successful execution of projects.
• Provide direction to the cross-functional team members as required.
• Prepare, review, and approve manufacturing processes, protocols, reports, and other controlled documentation.
• Lead process vs. actual build gap analysis activities.
• Participate in resolution of Non-Conformances and Corrective and Preventive Actions.
• Perform and present capacity analysis for existing and new products.
• Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
• Create and implement preventative maintenance and calibration services plans for new equipment
• Ensures processes and procedures are in compliance with regulations.
• Participate and help in the creation of preclinical and clinical studies
• Other tasks assigned by the manager.
• B.S. degree in Biomedical Engineering, Mechanical Engineering, Chemical Engineering or related engineering discipline.
• 3-5 years of experience in Manufacturing, R&D, and process development. Preferably in medical device or other regulated FDA/QSR and ISO environment.
• Good oral and written communication abilities
• Demonstrates good documentation practices and ability to maintain deadlines
• Demonstrated problem solving skills and hands-on technical aptitude
• Must be able to work independently under limited supervision as well as in a team environment
• Establishes and promotes a work environment that supports the Quality Policy and Quality System
• Master’s degree in Biomedical Engineering, Mechanical Engineering, Chemical Engineering or related engineering discipline.
• Experience with balloon catheters systems preferred.
• Experience leading small cross-function process development teams.
• 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.
• Experience creating 3D models and prints in Solidworks.
• Experience overseeing day-to-day operations in a catheter manufacturing line
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, and equipment in a cleanroom environment.
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. Urotronic, Inc. is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.
• Authorization to work in the U.S. required.
We offer a highly competitive salary, stock options, medical, dental, 401K plan, disability, life insurance, and flexible schedule.
Job Type: Full-time
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.