Medical Device Software Engineer & Quality Assurance Manager

Company Overview: Zargis Medical Corp. (www.zargis.com), a spin-off of Siemens, develops advanced diagnostic decision support products and services for primary care physicians, pediatricians, cardiologists and other healthcare professionals. Zargis was formed in 2001 when Siemens Corporate Research (www.scr.siemens.com) and Speedus Corp (www.speedus.com) co-invested to develop and market an advanced software-based technology designed to detect heart abnormalities through the analysis of heart sounds. Zargis? core product, known as Zargis Acoustic Cardioscan (Cardioscan?), is the first FDA-authorized computer-aided medical device of its kind.

Position Description: We are seeking an experienced, diversified and highly motivated engineer who is excited about the opportunity to oversee regulatory compliance and quality systems while developing software for a cutting-edge, rapidly growing organization. In the role of Medical Device Software Engineer & Quality Assurance Manager, your responsibilities will include:
?Designing and implementing software for a variety of PC-based medical applications, including Zargis' newly developed and groundbreaking Cardioscan product
?Managing and performing design control and quality assurance activities undertaken to insure regulatory compliance. Design control responsibilities will include the technical documentation of software code, participating in design reviews and conducting product verification and validation activities. Design control and quality assurance training will be provided if required.
?Implementing complex signal processing algorithms in C++
?Developing software in an FDA-regulated environment
?Fielding and documenting technical support inquires
?Supporting software configuration management

Position Requirements:
?BS and/or MS in Computer Science, Electrical Engineering, Math, Physics or related field
?Strong background in object-oriented programming
?Familiarity with FDA design controls, Quality System Regulations and GMP requirements a big plus?as is familiarity with ISO 13485
?Extensive software development experience (experience with the development of medical device software a big plus)
?Experience implementing complex signal processing algorithms in C/C++
?Experience in the development of multi-process or multi-threading applications
?Experience in packaging software for product use (i.e. InstallShield)
?Experience in the development of graphical user interfaces and multimedia applications
?Experience with document controls and configuration management methods
?Strong technical writing abilities and analytical skills
?Demonstrated ability to work independently and research innovative solutions to challenging technical problems
?Experience with Visual Basic, Microsoft Visual Studio .NET and other software development tools
?Willingness to wear more than one hat when required

Benefits: Zargis Medical offers an excellent benefits package that includes a 401(k), stock options, medical and dental coverage, long-term disability insurance, paid sick leave and paid vacation.

Relocation Assistance: May be considered

Zargis Medical is an equal opportunity employer.

For consideration, please submit a cover letter AND resume. NO RECRUITERS.