Quality engineering spring
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Mammotome , one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. At Mammotome, our expertise and compassion for breast care makes us the indispensable partner to physicians, clinicians and patients. Our drive for developing innovative technology is rivaled only by our compassion for the people we serve, from the clinicians and surgeons who demand consistently precise solutions, to the patients and families seeking peace of mind. When you join our company, you join in the fight against breast cancer. Working at Mammotome means you will have the opportunity to collaborate with a diverse, hardworking, high-performing team committed to improving patient outcomes. As a trusted leader in breast cancer diagnostics, we invite you to join us and support products you can feel passionate about! Learn about the Danaher Business System which makes everything possible. The Quality Engineering Co-op is responsible for supporting Design Assurance Quality Engineers with product improvement through implementation of quality management policies, procedures, specifications, test methods and measurement systems and working on compliance programs as it relates to new and existing products. This position reports to the Senior Manager, Design Assurance and is part of the Quality Engineering and Regulatory Compliance department located in Cincinnati, OH and will be an on-site role. In This Role, You Will Have The Opportunity To- Re-evaluate risk levels, risk acceptance, and state of the art assessments based on Post Market Surveillance data and provide support for risk management plans, reports, and utilize risk management tools such as FMEAs for NPD, VAVE, and Sustaining projects.
- Apply design controls and development processes to existing products.
- Assist Supplier Quality with periodic review of supplier files and maintenance of the Approved Supplier List.
- Support Regulatory compliance through assistance with documentation of Clinical Evaluations, Audit preparation, RegDesk and product registrations, as needed.
- Participate in and assist with the coordination of elements of investigations regarding customer complaints.
- Matriculated student working toward a Bachelor’s degree (BS) in a technical field (Biomedical Engineering, Bio engineering, Mechanical Engineering, Material Science or related field equivalent) required.
- Minimum GPA 3.0 within curriculum is required.
- Co-Op Term commitment: Start date: January 2025 - May 2025.
- Your semester should follow a Co-Op curriculum - University of Cincinnati students welcomed to apply
- Previous Co-op experience in an engineering and/or quality assurance and regulatory function is strongly preferred.
- Experience in medical device is preferred.
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