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Job Title: Software Engineer

 

Salary:  $71,400.00 - $89,000.00/Year
 

City/State: PA-Hatboro 

 

Description:  •Work within a Team of Software Engineers and Test personnel to manage the Configuration of Software during the design, implementation, integration, test and support phases of development. This Software will be used in infant care devices and related monitoring, ventilation and information management products.
•Ensure a rigorous and high quality software configuration management process with appropriate environment and tools. Configuration Management here is defined as the organized activity of maintaining the integrity of the Software configuration components.
•Complete Product S/W builds as required.
•Generate Verification Protocols, run Verification Tests and write Verification reports for Infant Care products focusing on Software and System testing. Support the documentation activities needed to meet internal and external requirements, specifications and standards. Test software in accordance with FDA and DMI guidelines.
•Generate Validation Protocols, run Validation Tests and write Validation reports for Infant Care products focusing on Software and System testing. Support the documentation activities needed to meet internal and external requirements, specifications and standards.
•Maintain technical ownership of the SW Configuration Management process.
•Perform scheduling & planning of software builds, software verification and software validation.
•Ensure process discipline and produce results on schedule – this is essential
•Represent the department and company factually and professionally in facility audits.
•Provide critical assessment and peer Design review for engineers and testers working in a team environment.
•Contribute to program planning, strategic planning and department-wide process improvement initiatives.
•Work to create a collaborative engineering environment with Software Teams in other Draeger Medical locations world-wide
•Ensure compliance to all internal SOPs and FDA and industry regulations. Develop and/or improve Software development processes, procedures and protocols.

Requirements: Proficient in the Configuration Management of Software utilizing state of the art tools and methodologies.
Skilled in the use of Software Configuration Management tools.

An engineering background in the medical device industry is desired.

Familiarity with SEI-CMM and other SW development models and metrics.

Ability to work independently and to stand up against peer pressure to assure V/V and testing are done at a high level.

BS/MS Software Engineering, Computer Science/Computer Engineering

Previous experience (3-5 years) in software development, and in an engineering software development environment.

A broad knowledge of Software engineering applications in the development of medical products and associated processes. This knowledge to include, but not limited to:
•Knowledge of C, C++, and assembly language programming
•Diverse knowledge of software development processes and SW Quality methods with demonstrated role in implementing improved SW development processes
•Embedded systems including real-time applications
•Windows-based systems
•Formal test requirements, protocols and report documentation
•Proficiency with Software requirements mapping and Software Defect Tracking tools
•Proficiency with Software Configuration Management tools

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