Sr. Quality Engineer, Research and Development at Medela LLC in Mchenry, Illinois

Job Description:

MEDELA, LLC in McHenry, IL

Sr. Quality Engineer, Research and Development

Hybrid Role based in McHenry, IL (Position requires several days per week onsite at our McHenry, IL facility)

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's US-based manufacturing and development facility is headquartered in McHenry, Illinois www.medela.com

Medela LLC is seeking a Sr. Quality Engineer, Research and Development

The Sr. 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

What We Offer our Sr. 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: Sr. Quality Engineer, Research and Development position-

• Bachelor’s 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- Sr. 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 support for product quality attributes/decisions


• Develops, coordinates, and supports technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE)


• Coordinates selected verification/validation activities (e.g., Electrical Safety, EMC, etc.) with external suppliers


• Recommends/reviews design or test methods and statistical data analysis, including sample size determination, for achieving required levels of product quality/reliability


• Support new test development and appropriate test method validation (TMV)


• Conducts/coordinates risk management activities (Risk Management Plan/Report, Risk Analysis and Control, Benefit-Risk Analysis, etc.) including review failure mode effects analysis (FMEAs)


• Maintains risk management file for the life of the device


• Provides support in conducting root cause analyses, preparation of CAPA and Product Risk Assessment

This is not a job description. More details will be provided regarding the Sr. Quality Engineer, Research and Development position.      

Caring has always guided everything we do at Medela. As a family company, you could even say it’s in our DNA. Over the last 60 years, our company has been devoted to the science of making the most delicate form of care simple, intuitive, and effective. Across different stages of life, our products go beyond form and function. They heal, nurture health, and build bonds – building better outcomes through equal parts physics, compassion, engineering, and humanity. And we have been caring for moms and babies, patients, and healthcare professionals for so long, we’ve turned it into a science. 

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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