Lead Software Engineer


: $108,680.00 - $159,340.00 /year *

Employment Type

: Full-Time


: Information Technology

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Lead Software Developer
Charlestown, MA

Client is looking for a motivated, highly creative and broadly skilled Lead Software Engineer to join its fast-growing twenty person team to play a key role developing our AST System. You will work closely with hardware and software engineers and scientists as well as manufacturing partners teams to bring our products to clinical trials, commercialization and launch. This position has the following responsibilities:
Lead creation of software requirements, design specifications and test plans for overall software infrastructure for client platform.
Design, develop and implement .NET and Microsoft SQL Server based software intended for FDA submission.
Perform all phases of software development life cycle
Closely work with hardware, software and UX design teams to capture and implement design needs.
Drive Test planning and Test case development and execution with an external SQA team

To perform these duties well, the individual must possess the following skills:
BS or MS in computer engineering, computer science, electrical engineering or similar field.
5+ years of industry experience developing production level software for clinical lab automation and in-vitro diagnostic instrumentation
5+ years of experience developing software in a regulated environment
Experience with 21 CFR 820 QSR, ISO13485 or IEC 62304 SDLC, documentation and procedures
Demonstrated proficiency in Windows software development including C#/.NET, ASP.NET, WPF, WCF, WinForms, Microsoft SQL server
Experience with cyber-security
Experience with Laboratory Information System integration is a plus
Excellent written and oral communication skills and a proven ability to work well on a multi-disciplinary team.
A strong desire to learn and succeed and play a key role in developing new technologies.
Passionate about changing how healthcare is delivered!

This work will drive development, verification and validation of a new generation of in vitro diagnostic devices. You must be creative, hardworking, and dedicated and must also have a strong track record of innovative problem solving in technical environments. You must also have a desire to grow by working on a fast-paced, highly-collaborative, multidisciplinary team.

Experis is an Equal Opportunity Employer (EOE/AA)

Associated topics: .net, application, backend, c c++, c#, developer, devops, perl, python, software programmer * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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