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- Columbia, MD 21046
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PRINCIPAL BIOMEDICAL ENGINEER
ComTec • Columbia, MD
Posted 2 months ago
Provide technical leadership on cross-functional teams throughout the development process from concept through commercialization. Develops design concepts and ideas for new products and product improvements. Oversees biomedical/mechanical engineering, design, and development work on assigned projects including prototyping and testing and evaluation. Manages CROs and performs human factors (usability studies), market assessment, or clinical research. Works with Business Development to explore acquisition or partnership opportunities. Works with Regulatory to develop strategy for product submissions and approvals. Responsible for adhering to design controls and documenting all product development work in a Design History File.
· Provide technical leadership to Biomedical Engineers and cross-functional teams within Client
· Conceptual design of new drug delivery systems or product enhancements for pre-hospital emergency care products
· Develop design inputs with associated justification for new product development
· Lead risk analysis and risk management activities including human factors studies
· Approve designs, test protocols, and reports
· Justify new product development and develop project plans and budgets
· Conduct business development research and due diligence activities
· Conduct research and publish as appropriate
· Comply with FDA Regulation and Guidance for Combination Products
· Excellent leadership, interpersonal, and organizational skills
· Conceptual and creative design skills
· Human factors and usability engineering experience
· Experience with various manufacturing methods such as injection molding, metal stamping, machining, etc.
· Strong mathematical, analytical, and reasoning skills
· Strong innovation skills
· Strong creativity astuteness
· Strong problem solving skills
· Strong research skills
· Strong in team work
· Strong written and verbal communication and presentation skills. Must be able to communicate effectively with staff at all levels in the organization.
· Strong business acumen – demonstrates knowledge of market and competition
· Proficiency in design software (preferably Solidworks) and other general computer software such as word processing, spreadsheets, presentations, etc.
· Experience in complying with FDA Design Control Regulations for Combination Products per 21 CFR Part 4 and/or Medical Devices per 21 CFR 820.30 and EU Medical Device Directives
· Ability to prioritize multiple responsibilities and to work on multiple projects simultaneously
· Responds to requests for service and assistance with professionalism, courtesy, and confidence
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
· Must be able to travel 25% of the time.
· Position requires regular onsite attendance, however, this position may be performed on a remote or telecommute basis on a temporary, short term basis.
· Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.
· Must have the ability to work effectively under and manage to strict production, time and performance deadlines.
· Must be willing and able to work beyond the hours typically defined as a “regular” workday, which may or may not include weekends and holidays.