This is a direct-client opening for a Senior Software Engineer located in Louisville, CO. This is a full-time position 
Responsibilities:
Collaborates with Quality Engineering, Marketing, Project Management, Regulatory, Operations, & other software development personnel (Offshore and on-site).
Analyzes and develops software requirements to determine feasibility of design within time and cost constraints.
Consults with hardware engineers and other engineering staff to evaluate interface between hardware and software, and operational and performance requirements of overall system.
Responsible for formulating and designing software systems, using state-of-the-art programming tools, scientific analysis, and mathematical models to predict and measure outcome and consequences of design.
Develops and directs software system testing procedures, programming, and documentation. Debugs software. Manages acquisition of tools and hardware with key vendors.
Consults with customers concerning troubleshooting of software in the field.

Experience/Qualifications:

Has demonstrated experience in understanding complex software products, production processes requiring software, and therapies. Has been a key member of technical teams in developing medical products. Demonstrates a high level of personal accountability for work output and project success/failures.
Has developed software code using C, C+, C++, Visual Basic, and other programming languages. Able to work with associated compilers to generate machine language code.  Identifies and resolves bugs and problems in a timely manner.  
Able to manage plan, write, and execute software verification & validation plans and reports.
Knowledgeable of FDA and International medical software design standards & regulation. Knowledgeable and experienced at developing and implementing robust Design Control activities per regulation including Risk Analysis, System Requirements, Software Requirements, Traceability Matrix, Verification Plans and Reports, Validation Plans and Reports, Device Master Records, Design History Files, Technical Files, etc. 
Experience working with Regulatory on publishing regulatory agency approval documents both domestic and international. 
Bachelor's degree (B. S.) or equivalent in Computer Science and 5-10 years of work experience in Software Engineering.
 
Please complete the following skills-matrix and send back with your response:

Full Name:
Degree/Major:
Total Experience as a Software Engineer:
Total Experience with C OR C++ OR Visual Basic:
Which one do you have Experience with:
Total experience with Medical Device Product Development:
Do you have experience in understanding complex software products, production processes requiring software, and therapies?
Have you been a key member of technical teams in developing medical products?
Current City/State:
Availability:
Phone Number:
When is the best time to reach you?
Current Salary:
Expected Salary:
Work Status:
What is the link to your Linkedin Profile?

All your information will be kept confidential according to EEO guidelines.