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Principal Biomedical Engineer

Townsend & Associates • Columbia, MD

Posted 1 month ago

Job Snapshot

Contractor
Travel - None
Experience - 12 to 99 years
Degree - 4 Year Degree
Medical Equipment, Pharmaceutical, Other Great Industries
Engineering, Pharmaceutical, Other

Job Description

Principal Biomedical Engineer

Description: 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.
 
Responsibilities:

  • Provide technical leadership to Biomedical Engineers and cross-functional teams within Meridian/Pfizer
  • 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

Principal Biomedical Engineer

Job Requirements

Principal Biomedical Engineer

NO CORP TO CORP! W2 ONLY!!!

Qualifications:

  • B.S. Degree in Engineering discipline with 12+ years’ experience OR M.S. Degree in Engineering discipline with 9 years’ experience OR Ph.D. in Engineering discipline with 7 years’ experience. Degrees must be in Engineering, preferably Biomedical Engineering or Mechanical Engineering
  • Excellent leadership, interpersonal, and organizational skills preferred
  • Conceptual and creative design skills preferred
  • Human factors and usability engineering experience preferred
  • Experience with various manufacturing methods such as injection molding, metal stamping, machining, etc. preferred
  • Strong mathematical, analytical, and reasoning skills preferred
  • Strong innovation skills preferred
  • Strong creativity astuteness preferred
  • Strong problem solving skills preferred
  • Strong research skills preferred
  • Strong in team work preferred
  • Strong written and verbal communication and presentation skills preferred
  • Must be able to communicate effectively with staff at all levels in the organization preferred
  • Strong business acumen – demonstrates knowledge of market and competition preferred
  • Proficiency in design software (preferably Solidworks) and other general computer software such as word processing, spreadsheets, presentations, etc. preferred
  • 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 preferred
  • Ability to prioritize multiple responsibilities and to work on multiple projects simultaneously
  • Responds to requests for service and assistance with professionalism, courtesy, and confidence preferred

Principal Biomedical Engineer

Job ID: 18-01870
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