Technical Skills:
RESPONSIBILITY AND AUTHORITY
This position is responsible for software development and the maintenance of software applications associated with medical product systems.
PRIMARY ACTIVITIES
• Software Project Leadership – Lead and coordinate multi-departmental software development projects in accordance with the Product Development Procedure, Quality Policy, and Software Development Procedure.
• Apply software engineering knowledge to the design and development of new products as well as product changes and enhancements.
• Solve software engineering problems at the subsystem through system level.
• Conduct testing utilizing existing test protocols or develop new ones as needed.
• Generate written protocols and reports.
• Assign work to technicians, temporary workers and others on the project team.
• Complete projects (including product enhancements) in a manner consistent with corporate objectives.
• Maintain accurate documentation of concepts, designs, architecture, detailed designs, interface specifications, code, code reviews, and testing.
• Conduct, lead, and participate in code and design reviews.
• Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company products.
• Provide software engineering and technical support of products introduced into both the domestic and international markets as well as physician in service programs.
• Oversee outside vendors and consultants as required.
• Maintain Quality System compliance in coordination with the Document Control, Clinical, and Quality Assurance functions.
• Provide software engineering support in the resolution of product complaints and/or safety issues.
• Work with other engineering, manufacturing, clinical affairs, sales and marketing, and quality assurance staff to coordinate pilot production of new products.
• Support company goals and objectives, policies and procedures, Quality System Regulations, and FDA regulations.
• Chair project meeting and design review.
• Perform documentation of software development as required by the product development and quality procedures.
• Perform other duties as may be required by management.
• Agile methodology
Any Graduate