Test Engineer, Medical Device

TEST ENGINEER, Medical Device

MEDELA LLC in McHenry, IL

Temporary Contract: 6 month assignment

100% On-site position

Are you looking to work with a lively and diverse team?

Are you looking to make a difference in the lives of mothers & babies?

Are you open to a temporary assignment?

Please go to https://www.medela.com/company/medelacares to learn about us

Medela is seeking a Contract Test Engineer who has the following:

• Extensive experience in the medical device industry, providing comprehensive verification test support for mechanical, electro-mechanical, and software components
• In-depth knowledge of quality management systems, regulations, and test standards relevant to global medical device development, including ISO 13485, CFR 820.30, AAMI/ISO 60601-1, AAMI/ISO 62304, and more
• Proficient in black box software testing
• Skilled in conducting a wide range of product performance tests, such as temperature, life-cycle, humidity, thermal shock, chemical, EMI/EMC, water ingress, and drop tests
• Experienced in creating and executing design verification plans, as well as designing custom tests.
  
  

Medela's US-based manufacturing and development facility is headquartered in McHenry, Illinois, with an additional facility in Elgin, Illinois. www.medela.com

This position requires an on-site presence in McHenry, IL

Education/Experience Requirements – Contract Test Engineer, Medical Device

• Bachelor’s degree (BS) in Mechanical, Electrical Engineering, Computer Science or related engineering field required
• Medical device industry experience required
• Minimum five years’ experience in test engineering required
• Electro-mechanical and software product test experience strongly preferred
• Ability to self-manage projects, i.e., tasks, resources, interfaces with external stakeholders
• Excellent verbal and written communication skills
• Ability to manage multiple conflicting priorities
• Experience working in an environment with global objectives
  
  

Position Responsibilities – Contract Test Engineer, Medical Device

• Works with the project design teams to: characterize / analyze / understand / debug the product design, and 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 various 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 the approved test plan. Monitor testing daily to ensure accuracy and timeliness in a 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
• Provide feedback and support for fixture design and development of new fixtures
• Manage external test resources, timelines, and deliverables
  
  

Pay Range starting at $65 per hour

This is not a job description. More details will be provided regarding the functions of this position.

At Medela, you will be joining a global community of colleagues, united by the purpose that drives our business: helping people. Medela exists to advance human health and well-being through knowledge-based and innovative human milk and medical vacuum solutions.

Our employees are empowered to serve this purpose in a family-owned company that is growing rapidly around the world. We value intensive exchanges, diverse perspectives, and unbureaucratic decisions. You will have the opportunity to develop at an international level, and witness the direct impact your work has on our company’s success.

If you are interested in this opportunity, we are looking forward to receiving your application.

For this position we only consider direct applications - thank you for your understanding.

As an EEO/Affirmative Action Employer, all qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, citizenship, sex, protected veteran status, age, physical or mental disability, medical condition, HIV/AIDs status, marital status, domestic partner status, sexual orientation, gender identity (transgender status), weight, height or any other characteristic protected by federal, state, or local law or ordinance.

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