Technical Quality Engineer, Research and Development - R1441

at Medela LLC in McHenry, Illinois, United States

Job Description

MEDELA, LLC in McHenry, IL

Technical Quality Engineer, Research and Development

Hybrid Role based in McHenry, IL


We make a difference in the lives of mothers and babies every day

Please go to to learn about us


Medela LLC is seeking a Technical Quality Engineer, Research and Development

The Technical Quality Engineer, Research and Development provides technical quality engineering support to the new product development teams focusing on design-related projects and deliverables required by the Design Control Process (DCP) to ensure quality, safety, usability, and performance within product design


Medela's US-based manufacturing and development facility is headquartered in McHenry, Illinois


What We Offer our Technical Quality Engineer, Research and Development

  • Excellent salary and bonus potential
  • Comprehensive benefits plan, which is affordable to our employees
  • 401K with a match
  • Pension Plan
  • Generous PTO package, plus 14 paid holidays
  • A great place to work!


Key Experience Needed: Technical Quality Engineer, Research and Development position-

  • Bachelors degree in electrical, Mechanical, or Industrial Engineering or equivalent (Mechanical, Biomedical, Natural Sciences)
  • Specific training in quality assurance/risk management required (e.g., ISO13485, ISO14971) and/or regulatory affairs
  • At least seven years work experience in a Product Development/Design Assurance function in a regulated environment (medical devices/Diagnostic instrumentation industry)
  • In-depth know-how and experience of Six Sigma methods such as VOC, DMAIC, DoE, Kaizen, etc.
  • Strong understanding of medical device design controls standards and regulations including ISO13485, ISO14971, MDR, MDD, etc.
  • In deep knowledge of Risk Assessment methodologies (e.g., PHA, HAZOP, Bowtie methodology, What-if hazard analysis, FMEA, FTA, etc.)
  • Statistical techniques, design of experiment (DOE), analysis, and sampling methods
  • Strong understanding of Test Method Validation (TMV)
  • Experience interacting with global stakeholders
  • English spoken and written fluently
  • Six Sigma Black Belt a plus


Position Responsibilities- Technical Quality Engineer, Research and Development

  • Provides Quality R-D and technical quality support to project teams in product development and in support of product care changes
  • Ensures that all product development projects meet applicable regulatory (local and international), customer, and stakeholder requirements
  • Review, assess and approve product design milestones and deliverables throughout the product development cycle to ensure compliance with customer and regulatory requirements
  • Proposes changes in design to improve system and/or product quality and reliability when necessary
  • Ensures that corrective measures meet acceptable quality and reliability standards
  • Provides technical...

    Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity

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Job Posting: 10936581

Posted On: May 18, 2023

Updated On: Jun 16, 2023

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