Senior Software Quality Engineer – Medical Devices

DEKA Research and Development; Manchester (NH); On-site; USD 90,000 - 120,000; Full time

Job summary

A medical technology firm located in Manchester, NH, is seeking a Senior Software Quality Engineer to enhance the development of life-changing medical devices. The ideal candidate will have a strong background in FDA regulated environments with at least 5 years of experience, proficiency in software validation, and excellent communication skills. Responsibilities include partnering with project teams, developing test strategies, and leading requirement discussions. This role promises a dynamic work environment where impactful solutions for healthcare will be developed.

Qualifications

• Minimum 5 years of experience in an FDA regulated industry.
• Experience with FDA QSR's, ISO62304 and GAMP5.
• Strong organization and technical leadership skills.

Responsibilities

• Partner with various teams to implement software tools.
• Lead requirement capture discussions.
• Develop test strategies and test protocols.
• Perform hazards analysis and mitigation design.
• Support development of custom software tools.

Skills

Project management

Technical documentation

Software validation

Communication

Education

MS/BS in Engineering, Computer Science or related discipline

Tools

Microsoft Office (Word, Excel, PowerPoint, Visio)

Job description

A medical technology firm located in Manchester, NH, is seeking a Senior Software Quality Engineer to enhance the development of life-changing medical devices. The ideal candidate will have a strong background in FDA regulated environments with at least 5 years of experience, proficiency in software validation, and excellent communication skills. Responsibilities include partnering with project teams, developing test strategies, and leading requirement discussions. This role promises a dynamic work environment where impactful solutions for healthcare will be developed.