Company: Medela LLC

Role: Risk Management Quality Engineer

Location: McHenry, IL

Are you seeking a new career opportunity with an internationally recognized organization where your skills and experience can be put to use to make a difference? Where you can contribute to projects that impact lives across the continuum of care? Where you work with a team of passionate individuals towards the same goal? If you're reading this and saying "yes" ...we want to hear from you.

Founded in 1961 by Olle Larsson in Zug, Switzerland, Medela continues to grow under the ownership of the Larsson family. Medela exists to advance human health and wellbeing through knowledge-based and innovative human milk and medical vacuum solutions. In Medela we have two business segments, Human Milk and Healthcare. The common denominator for the two segments is the medical vacuum.  We have developed and progressed our core competencies over the past 50 years and turned them into high quality and innovative products, in both segments.

About Medela Breastfeeding U.S.

For more than 50 years, Medela, supports moms every step of the way – through their pregnancy, in the hospital and at home so they can give the best to their baby, every day. As the #1 breast pump brand*, Medela is committed to improving mom’s breast milk feeding experience and her ability to successfully provide breast milk to her baby for as long as she chooses.  Every year, more than one million mothers in the U.S. rely on Medela's technology. For more than 30 years, Medela has focused on providing the best in research-based breast milk feeding products and clinical education to support moms' breast milk feeding journey.

About Medela Healthcare U.S.

As a global manufacturer of medical vacuum solutions, Medela Healthcare is driven by a passion to understand and resolve challenges facing the healthcare industry. This enables us to improve the lives of patients, doctors, and hospital staff through constant innovation. Medela Healthcare solutions include innovations in Negative Pressure Wound Therapy (NPWT), CardioThoracic Drainage, Surgical Suction, and Airway Suction.

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

www.medela.com

What We Offer:

• Excellent salary and bonus potential
• Comprehensive benefit plan, which is affordable to our employees
• 401K and pension plan
• Generous PTO package, including paid holidays
• Opportunities to learn, grow, and advance within the company

 Ideal Candidate:

• ASQ Quality Engineering Certification is preferred
• Excellent verbal and written communication skills
• Ability to manage multiple conflicting priorities
• Experience working in an environment with global objectives

 Role Requirements:

• Bachelor’s degree in Engineering or Science degree preferred
• Minimum 5 years applicable medical device related experience preferred, or minimum 10 years of progressive quality experience required
• Knowledge of ISO 14971 required

 Job Details:

• Interacts with cross-functional departments in planning, development, risk management, verification, validation and successful launch of new products
• Provides design assurance expertise and guidance and interprets product specific standards for supporting design activities
• Participates and helps guide Design & Process Failure Mode and Effect Analysis and Design Reviews for new products
• Ensures customer and consumer requirements are met by incorporating engineering principals in robust design and design for manufacturability
• Reviews and provides guidance for Design History Files, as per approved product change plans and DHF Remediation projects.
• Supports and establishes associated with risk management
• Complies with all federal, state, and local laws and regulations
• Follows all Company rules and regulations, including health and safety rules
• Successfully interacts with employees at all levels
• Regular, reliable performance of all job duties
• Travel as may be required to meet business and customer expectations
• Performs all other duties as assigned or as may be required from time to time

We Make It Easy: You can apply in less than two minutes. No passwords or accounts to register or sign up!

Our organization participates in e-Verify.

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.