Senior Software Quality Engineer - medical device

InnoTech Staffing • Manchester, NH

4d • Onsite

About The Position

InnoTECH Staffing is looking to hire a fulltime permanent Senior Software Quality Assurance Engineer to support the development of life-changing medical devices for a company located in the Manchester. NH area.

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.

Nice To Haves

• Experience with requirements definition and management for regulatory compliance a plus.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior