- Supports Design Assurance Quality Engineers with product improvement through implementation of quality management policies, procedures, specifications, test methods and measurement systems.
- Provides support for risk management plans, reports, and utilize risk management tools such as FMEAs for NPD, VAVE and Sustaining projects.
- Re-evaluate risk levels, risk acceptance, and state of the art assessments based on Post Market Surveillance data.
- Applies design controls and development processes to existing products.
- Assists Supplier Quality with periodic review of supplier files and maintenance of the Approved Supplier List.
- Supports Regulatory compliance through assistance with documentation of Clinical Evaluations, Audit preparation, RegDesk and product registrations, as needed.
- Participates in and assists with the coordination of elements of investigations regarding customer complaints. The essential requirements of the job include:
- 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: May August 2024 It would be a plus if you also possess previous experience in:
- Previous Co-op experience in an engineering and/or quality assurance and regulatory function is strongly preferred.
- Experience in medical device is preferred. At Mammotome we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Mammotome can provide.
Quality Engineering CoOp Summer 2024 - Cincinnati, United States - Danaher Corporation
Description
Mammotome associates know that every moment matters when it comes to advancing breast cancer diagnostics and surgical solutions. When you come to work at Mammotome, you're collaborating with a global team of engineers, designers, communicators, strategists, and specialists to improve patient outcomes. If you want to be inspired to grow every day, join our diverse, hardworking, high-performing team.
Be part of a company that's a trusted leader in breast cancer diagnostics and support products you can feel passionate about
Mammotome is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we're working at the pace of change to improve patient lives with diagnostic tools that address the world's biggest health challenges.
The Quality Engineering Co-op is responsible for working on compliance programs as it relates to new and existing products.
T his position is part of the Quality Engineering and Regulatory Affairs department located in Cincinnati, OH and will be hybrid. At Mammotome, our passion is driving innovative technologies that create efficiencies, while never forgetting that at the heart of every breast cancer journey is a patient.
You will be a part of the Quality Engineering and Regulatory Affairs function and report to the Manager, Design Assurance in Quality and Regulatory Affairs
responsible for the execution and implementation activities for New Product Development, VAVE, and Sustaining Engineering projects. This team is responsible for compliance programs as it relates to new and existing products. If you thrive in a multifunctional, fast paced role and want to work to build a world-class organization—read on.
In this role, you will have the opportunity to :
At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
The EEO posters are available here ) .
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at to request accommodation.