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Principal Biomedical Engineer

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Engineering
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181AB Requisition #
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JOB SUMMARY:
Directs and coordinates activities of the engineering department for organizational product development, testing and maintaining throughout the life cycle of the product by performing the following duties, personally and through subordinate supervisors. The job will also include project leadership and management assignments of a small team of software developers. 

ESSENTIAL/PRIMARY DUTIES:
  • Responsible for design and development of systems that span the engineering disciplines of biomedical, algorithm development, electrical, embedded software, and/or PC software.
  • Provide physiological expertise in medical and biological sciences to facilitate advances in non-invasive diagnostics devices. This expertise will be leveraged for device design, clinical study design, clinical study data analysis, design of experiments, and usability.
  • Serve as technical leader in area of expertise.
  • Research and recommend design options and perform experiments to determine potential design feasibility or application.
  • Prepare technical reports including internal and interfaces documentation.

SECONDARY DUTIES:
  • Supervise junior teammates, interns, and/or contractors.
  • Experience with Medical Device Directive (MDD), ISO 13485, FDA design controls or similar regulatory environment.
  • Demonstrated experience in successful project and people management
  • Participate in design reviews, V&V activities, and product development activities as necessary
  • Follow company quality management system and FDA regulations.

EDUCATION and/or EXPERIENCE:
  • Masters Degree in Biomedical Engineering, Biotechnology, or equivalent technical Degree. Ph.D. preferred, 10+ years related engineering experience

COMPETENCY/SKILL REQUIREMENTS: 
  • Demonstrated technical experience in applying bioscience theory to engineering and designing of medical devices.
  • Experience in system engineering, device development, and broad technical expertise.
  • Experience with algorithm development and research with Matlab
  • Experience with Matlab, C code development, and/or embedded software development.
  • Familiarity with .NET and C# programming
  • Self-starter; highly-organized; detail-oriented; highly-motivated; team player; analytical; strong interpersonal & verbal/written communication

SUPERVISORY RESPONSIBILITIES: 
  • May supervise interns, contractors, and/or junior teammates

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