Senior Software Quality Engineer

About the role

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

Responsibilities

• 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.

Requirements

• MS/BS in Engineering, Computer Science or related discipline with at least 5 years’ experience in an FDA regulated industry.
• Working knowledge of FDA QSMR’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.

Qualifications

• Experienced in software product development or software tool validation of medical devices.

Skills

• Strong organizational and communication skills.
• Ability to lead and mentor a team.
• Knowledge of FDA regulations and standards.
• Experience with software development lifecycle and quality assurance.
• Proficiency with Microsoft Office tools.

Benefits

• Competitive compensation package.
• Flexible work schedule.
• Professional development opportunities.
• Work in a supportive and innovative environment.

Pay

• $80,000 - $100,000 annually based on experience.

Schedule

• Full-time position.

Application

To apply for this position, please visit our website and submit your resume and cover letter.