Senior Software Validation Engineer

1 day ago


Warren, Ohio, United States Cooper Companies Full time
About Cooper Companies

Cooper Companies is a leading fertility and women's healthcare company dedicated to delivering innovative solutions that enhance the work of healthcare professionals and benefit families.

We offer a wide range of clinically relevant medical devices, including testing and treatment options, to women's healthcare providers.

Our commitment to quality and customer satisfaction is reflected in our products and services.

Job Description

The Senior Software Validation Engineer will be responsible for providing software design and implementation support for Quality Engineering in New Product Development and Sustaining projects.

This individual will apply knowledge of software design control principles to positively influence software development efforts and ensure the product software is developed and manufactured in accordance with applicable industry standards, regulatory requirements, and customer requirements.

The successful candidate will actively represent the Quality function on product/process/software development teams, mentor other disciplines as needed, and provide guidance to Engineering staff and other personnel to ensure design control requirements are met.

Key responsibilities include leading or participating in the investigation of complex product & software problems, identifying and managing corrective actions, and participating in design reviews to evaluate designs and identify alternative design solutions.

The ideal candidate will have a strong background in medical device software validation, experience with embedded systems, and knowledge of applicable laws and regulations, including ISO 13485, ISO 14971, and IEC 62304.

Additionally, the candidate should have excellent communication and interpersonal skills, strong analytical and problem-solving skills, and the ability to read and understand highly technical material.

We offer a competitive total compensation package, including medical coverage, 401(k), parental leave, fertility benefits, paid time off, and multiple other perks and benefits.

Please visit our website to learn more about Cooper Companies and the benefits of becoming a member of our team.



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