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 https://www.medela.com/company/medelacares 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 www.medela.com
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
