Senior Software Quality Engineer at DEKA Research & Development

Manchester, New Hampshire, United States -

Full Time

Start Date

Immediate

Expiry Date

12 Sep, 26

Salary

0.0

Posted On

14 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Software Quality Assurance, Requirement Capture, Test Strategy Development, Hazards Analysis, Failure Modes Analysis, Software Tool Validation, FDA QSMR, ISO62304, GAMP5, Technical Leadership, Microsoft Office, Visio, Regulatory Compliance

Industry

Biotechnology Research

Description

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. 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 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 About DEKA: One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research and Development, where we are taking the same innovation and cutting-edge technology into the modern age. Behind DEKA’s brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.

Responsibilities

Lead the implementation of critical software tools and convert user needs into technical requirements for medical devices. Develop system-level test strategies, protocols, and perform hazard and failure mode analyses.