Senior Software Quality Engineer

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

Job summary

A medical tech company located in Manchester, NH is seeking a Senior Software Quality Engineer. In this role, you will develop and support vital software tools for medical devices, collaborate with diverse teams, and ensure compliance with FDA regulations. The ideal candidate possesses at least 5 years of experience in an FDA regulated environment and a degree in engineering or computer science. Excellent technical and communication skills are essential for success in this position.

Qualifications

• At least 5 years' experience in an FDA regulated industry.
• Proficient with FDA QSR’s, ISO62304, and GAMP5.
• Ability to write clear procedures.

Responsibilities

• Partner with various teams to implement critical software tools.
• Lead requirement capture discussions.
• Develop system level test strategy and specifications.
• Conduct hazards and failure modes analysis.
• Support custom software tool development.

Skills

Software product development

Technical leadership

Communication

FDA regulations

ISO62304

GAMP5

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.