Senior Software Quality Engineer

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

DEKA Research and Development, housed in Manchester, NH, is looking for a dynamic, results driven and inventive Senior Software Quality Engineer to support the development of life-changing medical devices.

How you will make an impact as a Senior Software Quality Engineer:

• Partner with Project Managers, System Engineers, Quality Systems Management & Information Technology to support the implementation of critical software tools.
• Lead requirement capture discussions to convert users' needs into technical requirements.
• Develop system level test strategy, test specifications and test protocols.
• Hazards analysis, failure modes analysis and mitigation design.
• Support development / configuration of custom software tools.
• Support device development teams through delivery of modern, validated software tools.
• Use experience within software product development or software tool validation of medical devices to provide guidance and assistance.

To be successful in this role, you will need the following skills and experience:

• MS/BS in Engineering, Computer Science or related discipline with at least 5 years' experience in an FDA regulated industry.
• Proficient with FDA QSR's, ISO62304 and GAMP5.
• Excellent organization, communication, and technical leadership skills.
• Proficiency with Microsoft office tools: Word, Excel, PowerPoint, & Visio.
• The ability to clearly write procedures that others can easily follow.
• Experience with requirements definition and management for regulatory compliance a plus.