Senior Quality Engineer - Design Assurance

This job is with Danaher, an inclusive employer and a member of my Gwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

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 Senior Engineer, Quality Assurance for Mammotome is responsible for supporting Design Control and Risk Management activities to bring new products to market, ensuring product compliance to applicable standards and regulations, and collaborating with cross-functional teams to maintain adherence to Mammotome’s Quality Management System.

This position reports to the Senior Manager, Design Assurance and is part of the Quality Assurance and Regulatory Compliance department located in Cincinnati, Ohio and will be an on-site role.

• Serve as the Design Quality Lead during all stages of design controls projects with manageable risks and resource requirements through support of user needs, product requirements, design specifications, design verification and validation strategies, usability studies, process qualifications, design reviews and transfer.
• Generate and independently maintain project risk management file for New Product Development (NPD) and sustaining projects, including risk plans, hazard/failure mode effects analysis, risk mitigations and effectiveness checks, and risk management reports using principles from ISO 14971.
• Provide independent technical support of design control and risk management to advance problem solving of systemic quality issues and in support of internal and external audits (i.e. FDA, ISO, and MDSAP).
• Author updates to applicable corporate quality procedures in response to new standards, regulatory requirements, or process improvement initiatives—ensuring the Quality Management System (QMS) remains compliant and efficient.
• Assist in training company employees, other Design Assurance Quality Engineers on the principles of Quality and other QMS elements.

• Bachelor’s degree in engineering from an accredited college or university
• Minimum of 5 years of experience in an engineering role in the medical device industry
• Comprehensive knowledge and experience of international medical device quality systems regulations and standards, including but not limited to 21 CFR 820, ISO 13485, and ISO 14971
• Strong knowledge and experience in the application of design control principles to medical device design and development
• Knowledge and experience with process validation and manufacturing qualifications

• Ability to travel – Must be able to trave up to 10% of the time. Overnight travel will be required.
• Must have a valid driver’s license with an acceptable driving record
• Ability to lift, move or carry equipment up to 10lbs

• Leading audits with external auditors and/or Notified Bodies
• Non-product…