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Purpose of the Position:
Management of Software Development Activities and Support of Algorithm Development
Essential Duties and Responsibilities (other duties may be assigned):
- This position will be responsible for the specification, design, development, implementation, testing, validation and support of software systems and products encompassing embedded microprocessor-based instruments, dedicated Windows based product software and stand-alone PC software applications and development tools in a .NET environment.
- Background in engineering mathematics, including curve fitting and algorithm development. Experience with mathematical modeling and simulation, familiarity with statistical methods as applied to scientific, genetic and biological data analysis desirable.
- Management of outside contractors supporting maintenance of existing product software and new software development. This responsibility will involve planning and budgeting, as well as maintaining a detailed technical understanding of the functions and implementation of the software, which is .NET based. Monitoring of the contractor and its staff to track progress, performance and budget is required.
- Will contribute to the development of a sophisticated diagnostic instrument that includes chemistry, electronics, embedded hardware and software and Windows based applications and databases. Should be able to develop an understanding of the operation, theory and interactions of these subsystems.
- Will be responsible for support to the product after market introduction.
- Should be able to contribute hands-on code design and development in C++, C# as required.
- Must have strong project management skills and experience. Should have excellent facilitation, communication, leadership, teamwork and organization skills
Supervisory Responsibilities:
Management of internal personnel engaged in software development and product support and management of an outside contractor developing a large software project.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- (1) Technical background in embedded real-time systems including hardware and software would be highly desirable.
- Programming experience in Windows, C and .NET environment.
- (2) Must have experience developing software under FDA design control requirements and be familiar with Quality System Regulations, document control and all aspects of software quality assurance.
- (3) Must have experience in the medical device, IVD, or biotechnology industries, preferably directly involved in commercial product development.
- (4) Knowledge of chemistry or biochemistry would be beneficial.
Education and Experience:
BS in a scientific or engineering discipline plus ten years software development experience in a commercial environment. Mathematical background desired. Experience in some or all of the following areas is required. Complex mathematical algorithms, database systems, SQL, Windows based applications, C, C++, .NET, VB, visual studio. Medical devices, IVD’s, or molecular diagnostics. Project management, including managing outside vendors. FDA quality regulations, design controls, and software development requirements.
Language Skills: Must be proficient in writing, and communicating in the English language.
Mathematical Skills: Must be consistent with BS, engineering level or higher education
Reasoning Ability: Good problem solving, judgment and decision making skill are required.
Certifications, Licenses, Registrations:
Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work entails regularly performing tasks while working at a computer, desk, laboratory bench or automated machine. Work may involve occasional climbing or balance. Work entails occasional lifting and/or moving up to 25 pounds. Work occasionally requires travel between buildings. This is typically completed by foot or by car.
The employee’s sensory modalities (vision, hearing, smell) and physical capabilities (ambulation without mechanical assistance, strength, coordination, dexterity, range of motion) must be sufficient to independently perform duties/functions of the position.
Work Environment: 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 will involve a combination of office and biotechnology laboratory environments. While performing the duties of this job, the employee may be exposed to hazardous chemicals, blood Bourne pathogens, automated equipment, and high levels of noise and vibration. The noise level in the work environment is usually moderate. |
