Project Engineer II

Organizes, controls, and completes engineering projects necessary to maintain the requirements, specifications, and drawings for production, testing, and delivery of the company's medical devices to its customers.

  • Identifies project objectives by reviewing engineering change requests, quality data, design transfers, compliance standards, and other requirements.
  • Determines the scope of tasks affecting supplier arrangements, inventory control, risk management, manufacturing and service processes, marketing, quality, and regulatory affairs.
  • Creates and maintains project schedules to meet the objectives and time requirements, identify resource assignments, and track progress.
  • Develops specifications to meet design requirements and to comply with standards.
  • Procures prototypes and pre-production parts for evaluation and first-article inspections.
  • Develops test procedures and completes testing to verify specifications meet the design requirements.
  • Controls project plans by reviewing design output specifications, identifying schedule changes, and recommending actions.
  • Maintains compliance with quality procedures, company policies, and regulations.
  • Maintains control of project files and design outputs, and facilitates the completion of their revision, review, and approval.
  • Contributes to cross-functional team efforts as needed.
  • All other duties, as assigned.
  • Mechanical, Biomedical, or Electrical Engineering or equivalent
  • 7 years ME, EE, or BME experience, preferably in the medical device industry
  • Design Skills
  • Project Management
  • Manufacturing Methods and Procedures
  • Risk Analysis
  • Experience with process improvement
  • Technical Understanding of the following: Documentation Skills, CAD, Circuit Design
  • Quality Management System Verification/Validation
Project Engineer II
Indianapolis, IN
Human Resources

HIFU company


10130 Perimeter Pkwy, Suite 250
      Charlotte, NC 28216

(888) 874-4384

Mon - Fri: 9:00 - 5:00

Latest News

11 January 2017

Charlotte, NC (PR Newswire) January 11th, 2017 - SonaCare Medical, leading developer and manufacturer of high intensity focused ultrasound (HIFU) technologies, reports receipt of 510(k) regulatory clearance to market its...

05 October 2016

Charlotte, NC (PR Newswire) Oct 5th, 2016,  SonaCare Medical, leading developer and manufacturer of High Intensity Focused Ultrasound (HIFU) Technologies, reports over 40 acquisitions of Sonablate® technology since the device...