Medela is seeking a Test Engineer who has the following:
Strong experience in the medical device industry; full verification test support for mechanical, electro-mechanical, and software components
Strong knowledge of quality management systems, regulations, and test standards relevant to global medical device development; ISO 13485, CFR 820.30, AAMI/ISO 60601-1, AAMI/ISO 62304, etc.
Working experience in a variety of product performance tests such as temperature, life-cycle, humidity, thermal shock, chemical, EMI/EMC, water ingress, drop, etc.
Experience in design verification plan creation and execution and custom test design
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
What We Offer our Test Engineer, Medical Device
Excellent salary and bonus potential
Comprehensive benefits plan, which is affordable to our employees
401K with match
Pension Plan
Generous PTO package, including 14 paid holidays
Education/Experience Requirements - Test Engineer, Medical Device
Bachelor’s degree (BS) in Mechanical, Electrical Engineering, Computer Science or related engineering field required
Medical device or aerospace 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 – 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
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.
