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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 multidepartmental 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
TRAVEL REQUIREMENTS This position may require business travel.
DESIRED SKILLS AND QUALIFICATIONS
Project Leadership Skills
Windows Programming
Additional Software Language Expertise
Good communications skills both written and oral.
Team player works well with others
Full Time