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Sr. Principal Engineer
Ref No.: 18-14243
Location: Deerfield, Illinois
Position Type:Engg
Start Date / End Date: 10/01/2018 to 09/30/2019
Call Notes:
Looking for a more seasoned engineer. Systems engineer. Minimum 8 yrs.
Agile Exp.
They will be overseeing development of the system, requirments gathering, involved in design (system design)
80% requirments caputring, documenting, transferring in into Agile process.
Risk Driven
Computer Scinece, Biomedical Engineers etc.
The product is a electromedical compotment of a medical device.
This is a early stage product development for Baxter.
They have to have the Risk piece, 14971 is what they are regulated by, hence a candidate from a regulated industry will work. Automobile industry will work but they dont have the patient safety (14971 risk exp).
Scrum master overseeing the system requirments, requirent gathering etc. He does not need a Scrum master.
C++, Python is the implementation. They dont need to prgramer/coder but have to have the system exp.

Job Description:

Contractor Job Title: Medical Device Systems Engineer and Agile Scrum Master
  • Medical Device Systems Engineer with 8+ years experience.
  • A successful applicant can lead development of new medical devices through the gathering and analysis of user needs, translation of needs to system and software requirement, and risk management.
  • The applicant will coordinate with software, electrical, and mechanical functions within R&D as well as coordinating with Risk Management, Compliance, Reliability, Clinical, Human Factors, Marketing and Regulatory.
  • The applicant must function within a team environment and provide clear feedback to supervisors and team members.
  • The applicant will be adept at Agile product development and able to serve as the Scrum Master for software-focused projects.

Critical skills and experience include:
  • Bachelor's degree engineering.
  • Solid technical understanding of gathering and maintaining requirements and traceability.
  • Solid understanding of medical device risk management
  • Solid understanding of design configuration management
  • Must be able to provide technical solutions that reflect understanding business objectives and cost implications.
  • Ability to resolve competing constraints between interrelated functions (Engineering, Risk Management, Compliance, Reliability, Clinical, Human Factors, Regulatory)
  • Agile process, including as a Scrum Master

Preferred skills and experience include:
  • Experience with the development of software focused electronic medical equipment.
  • Experience with Medical Device design controls and understanding of Good Document / Manufacturing Practices in the area of design controls, including FDA-21 CFR 820.30 and ISO 9001.
  • Working understanding of IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
  • DOORs and software development experience are advantages

An engineer in this role must demonstrate the following behaviors:
  • Excellent communication skills
  • Accountability for deliverables
  • Self-motivated and committed to deadlines
  • Ability to prioritize multiple tasks
  • Proposes and drives solutions to technical problems
  • Gives and accepts constructive feedback; takes accountability for own behavior and adjusts appropriately
  • Fosters creative thinking and teamwork to resolve conflicts

What are the key items you want me to look for on resumes before sending them to you?
  • System requirements creation/management
  • Medical device new product development
  • Risk Management
  • Agile process Scrum Master
  • System verification creation/execution