To apply, send an email with a subject of JOB CODE M-020 to HR@ Historx.com.  Attach a CV to the email and use the body of the email to convey the additional information that you might have included in a cover letter. Do not include a separate cover letter.  HistoRx, Inc. is an Equal Opportunity Employer.

HistoRx, Inc. has an opening for a Software Manager. This person will report to the Director of Development.   Your role will be to oversee the design, development, implementation and commercialization activities for the software associated with the AQUA® system.  The remit will include, but is not limited to:

• Oversee software engineering resources and coordinate activities within the group.
• Further the development of, and adherence to, regulatory guidelines concerning development of software as part of a medical device. 
• Review of system architecture and integration to insure system integrity at appropriate regulatory levels.
• Lead software design, development, and testing throughout the software life cycle in a regulatory environment.
• Plan and execute projects to develop the platform, operating with other associated groups within the company.
• Plan and conduct software V&V&T compliant with FDA QSR and other appropriate regulatory standards.

Required Qualifications:

• 5 years experience in a GUI Software development environment including detailed knowledge of software architecture, design, and implementation of C#/C++ in the .NET environment.
• 5 years experience in design and development of software for a medical device in a controlled environment.  Strong preference given for applicants with experience in development requirements for medical device submission. 
• Understanding and experience with software quality assessment tools.
• Experience working with hardware control/interface software and integration.  Automation a plus.
• Experience with database design, implementation and management in a laboratory/bioinformatics environment.
• Graduate degree in life science, mathematics, or computer science or 5-8 years equivalent experience.