Engineer II

Overview

On Site
$35 - $36
Contract - W2
Contract - 11 Month(s)

Skills

Medical Device
FDA
disposables

Job Details

Immediate need for a talented Engineer II. This is a 11+months contract opportunity with long-term potential and is located in Round Lake, IL/Plymouth MN (Onsite). Please review the job description below and contact me ASAP if you are interested.

Job ID:25-70235

Pay Range: $35 - $36/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan .

Key Responsibilities:

  • Lead and support small to medium sized projects with global cross-functional teams in the implementation of design changes (e.g. new features, suppliers, materials, labeling, CAPA/NCR, cost reduction, remediation).
  • Identify, investigate, and solve engineering problems utilizing risk-based and customer focused approaches and engineering tools. (e.g. dFMEA, Human Factors Engineering, statistical software, CAD).
  • Create, modify, and maintain design history file documentation including protocols, reports, design specifications, labeling, and design drawings.
  • Develop and execute test method validations, product testing, and verification / validation activities.
  • Build prototypes and models. May operate machine tools, design and build basic tooling, test fixtures and assembly equipment.
  • Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance.

Key Requirements and Technology Experience:

  • Key Skills:Medical Device, FDA, disposables.
  • Working knowledge of plastics materials and processing such as injection molding, extrusion, ultrasonic welding, UV/solvent bonding, and sterilization.
  • Working knowledge of CAD and PDM enterprise software (e.g. Creo, Solidworks).
  • Working knowledge of FDA Design Controls and ISO 13485 Quality Management Systems.
  • Working knowledge of ANSI/AAMI/ISO 14971 Medical Devices - Application of Risk Management to Medical Devices.
  • Takes initiative with a high aptitude for learning, innovation, and implementing best practices and continuous improvements.
  • Strong collaboration, verbal and written communication skills.
  • Strong attention to detail, organized, and able to independently manage multiple priorities.
  • Ability to read, write and comprehend English.
  • Experience and/or Background BS in Mechanical, Plastics, Biomedical Engineering or a related field, MS preferred.
  • 3 - 5 years of related experience in Class II or Class III disposables medical product development.
  • Design for Six Sigma (DFSS) training or certification preferred.

Our client is a leading IT Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

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