Job Description

Under minimal supervision, this role is responsible for designing and developing software applications,

including performing coding, debugging, testing, and troubleshooting throughout the application

development process. This role analyzes, evaluates, and provides maintenance and support for assigned

applications.

ESSENTIAL FUNCTIONS:

• Develop Automation of calibration process and statistical process control for an In-vitro Diagnostic product
• Develop a data processing system for the research and optimization of signal processing algorithms
• Subject Matter Expert (SME) on the Medical Device with regards to manufacturing, clinical use and firmware
• Manage embedded firmware and data base applications
• Develop test procedures to ensure quality
• Support future changes to the calibration software to meet the demands of the operations Group
• Collaborate cross-functionally with product Scientists and Engineers
• Carries out duties in compliance with established business policies.
• Perform other duties & projects as assigned

INTERACTIONS:

• Project Managers, R&D teams and development teams to address instrumentation problems, identifies
• solutions. Interacts with external contractual developers in preparing software design control
• documentation and in identifying and resolving anomalies. Provides support to Technical Services in
• resolving instrumentation anomalies identified in the field.

WORK ENVIRONMENT:

• The work environment characteristics are representative of both an office and laboratory environment and include handling of viral and bacterial hazards as well as infectious or potentially infectious bodily fluids, tissues and samples.

PHYSICAL DEMANDS:

• Position requires ability to lift up to 20 lbs. on a regular basis.? Walking, standing, and sitting for long periods of time (up to 75% of the day) are routine to accomplish tasks in this role.? Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Personal protective equipment is required as posted. Occasional travel required. Travel includes airplane, automobile travel and overnight hotel.

EDUCATION, SKILLS & EXPERIENCE

• Bachelor’s degree or equivalent in Software Engineering or Computer Science or related field
• 5 plus years of related experience or a combination of work experience and software development experience that demonstrates the ability to work in multiple disciplines with emphasis on Software Engineering, C-# programming; SDLC; Design Control; SQL server Programming

Skills and Knowledge

• Extensive knowledge of validation and compliance working environments
• Combination of Software Engineer and Electrical / Biological Engineering
• Preferable Medical Device – IVD
• Knowledgeable of federal and other regulations, e.g. QSR’s, ISO, ISO 13485, CMDR, and FDA regulated environment
• Appropriate office computer skills (e-mail, word processing, statistical, spreadsheet and
• graphing software)
• Demonstrates commitment to the development, implementation and effectiveness of Company
• Quality Management System per ISO, FDA, and other regulatory agencies
• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities

Company Description

www.peaktechnical.com