Job Description

We are looking for a TEST Engineer - Product Development to join the team! This is a contract position that is on-site in McHenry, Illinois .

Responsibilities:

• Work with the project design teams to characterize, analyze, understand, and debug the product design; provide recommendations on closing any gaps between the product implementation and product requirements.
• Provide full verification test support to project design teams for mechanical, electro-mechanical and software components of products.
• Design verification plan creation and execution and custom test design.
• Execute a variety of product performance tests such as temperature, life cycle, humidity, thermal shock, chemical, EMI/EMC, water ingress, drop, etc.
• Manage the setup, execution, and teardown of tests in accordance with approved test plan. Monitor testing daily to assure accuracy and timeliness in test environment.
• Provide compliant documentation of testing and Evidence of Test (EoT) in lab database and test reports.
• Develop test protocols and reports, conduct reviews. and obtain test report approvals.
• Maintain trace matrices in Design History Files (DHF).
• Complete verification summary report for each product testing cycle.
• Strong knowledge of quality management systems, regulations, and test standards relevant to global medical device development such as ISO 13485, CFR 820.30, AAMI/ISO 60601-1, AAMI/ISO 62304, etc.
• Participate in continual improvement activities, identifying potential problem areas and solutions. Effectively communicate ideas and results to other engineers and management.
• Provide feedback and support for fixture design and development of new fixtures.
• Manage external test resources, timelines, and deliverables.

Requirements:

• Bachelor’s degree in Mechanical, Electrical Engineering, Computer Science or related engineering field is required.
• Minimum of five years’ experience in Test Engineering is required.
• Electro-mechanical and Software Product Test experience is strongly preferred.
• Medical Product or Regulated Environment experience is required.
• Experience working in an environment with Global Objectives is preferred.
• Minimum of five years' experience of Regulated Medical Device industry experience is required.
• Planning at a project level -- at minimum, owning a sub-component of a project, is required.
• Developing Test Protocols is required.
• Experience in Mechanical, Electro-mechanical, or software product testing is required.
• Conducting medical device product performance testing, such as temperature, life cycle, humidity, thermal shock, chemical, EMI/EMC, water ingress, drop, etc. is required.
• What software programs should you have experience with?
• Gooey level testing - Entering test cases into a test case software (we can train on that) and entering test cases into an electronic system.
• Black Box Software Testing - Where you can’t look inside, but you give it an input and you expect it to do that. You can see where it’s not working but you aren’t sure why (you don’t see under the hood). This position will be doing Black Box testing, not white box testing.
• 70% Mechanical/Electrical Testing, 30% Software Testing – You won’t do detailed software verification, but you will do a higher level of software testing. The primary role will be electro-mechanical testing.

Details:

• This is a contract position that is on-site in McHenry, Illinois .
• Length of Contract: 6 months
• Location: 100% on-site in McHenry, IL
• Schedule: Monday - Friday, 8:00 am - 5:00 pm
• Pay: $60-100/hour BOE
• This is a W-2 position. No B2C/C2C. No sponsorship. No relocation.

Malone is an Equal Opportunity Employer.

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