BD (Becton, Dickinson and Company) Senior Software Engineer in Louisville, Colorado
Job Description SummaryCollaborates 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.
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.
Education and experience:
Bachelor's degree (B. S.) or equivalent in Computer Science and 5-10 years of work experience in Software Engineering.
5 + years Medical Deviceexperiencerequired.
Demonstrated experience in understanding complex software products, productionprocessesrequiring 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 projectsuccess/failures.
Off shore collaboration experience a plus.
Experience in software code using C, C+, C++, Visual Basic, and other programming languages highly preferred.
While performing the duties of this job, the employee is regularly required to sit, talk, and hear. The employee is frequently required to use hands to handle and feel. The employee must be able to lift or move boxes of product/raw materials.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position is in an office environment.
Primary Work LocationUSA CO - Louisville
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status