Location: Suwanee, GA
Reports to R&D Manager
Position Type: FLSA: Contract to Possible Hire/Exempt
Travel Required: ~ 10%
This senior position focuses on managing software development projects for new and in sustaining existing software products discovery, invention, design, development, support, and documentation of developing technologies for medical and non-medical devices uses. Will determine and develop approaches to software and system solutions. Software engineers shall demonstrate full use and application of standard principles, theories, concepts, and techniques and work on problems of diverse scope and complex assignments, where analysis of data requires evaluation of identifiable factors. To obtain desired results, reasonable exercises of judgment are expected within defined practices and policies. Incumbent will also design, direct, or modify of components of systems as needed and shall be able to provide technical guidance to other personnel.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Apply knowledge of engineering principles and practices in broad areas of assignments and related fields.
- Use advanced techniques and the modification and extension of theories, precepts, practices, related sciences, and disciplines.
- Develop software in accordance with ANSI/AAMI IEC 62304 software life cycle that includes planning, design tests, includes unit testing, and validates software to meet the high-reliability and high-performance standards required for medical devices.
- Follow internal policies and procedures to complete work assignments and comply with QSR/ISO/regulatory and standards requirements for design controls for the development of medical device electronics and embedded software.
- Consult with supervisor or project leader concerning unexpected or unusual problems and developments.
- Perform as a staff consultant and opinion expert on technical specialty regarding software or a program function.
- Work with staff engineers on a variety of projects, including writing and debugging code for new and existing products, as well as developing code for product test fixtures.
- Estimate manpower needs and schedules for software activities.
- Practice company safety and quality policies/procedures and actively require conformance.
- Responsible for participating in design reviews and pre-validation assessments to ensure the safe and environmental conformance.
- Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
- Act as a mentor for junior engineers.
- Other duties may be assigned.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- 10+ years’ experience as a Software Engineer in the medical device field.
- Degreed in in computer science and software engineering
- Experience managing a software team and / or projects
- Expert knowledge with assembly language and high-level programming languages such as C, C++.
- Expert knowledge of Physics, Advanced Mathematics, and basic engineering fundamentals.
- Ability to perform software simulation and project documentation in an organized manner and be able to correctly interpret results.
- Understanding of object-oriented programming, design methodology, UML modeling, data structures and algorithms
- Strong knowledge and experience with embedded programming and multi-threaded/real-time application development.
- Linux operating system experience, Linux optimization, device driver, and cross-compiler tool set development helpful.
- Develop the software layers to interface to USB devices, wireless devices such as WIFI, RFID, and Bluetooth.
- Able to interpret electrical interface(s) from schematics.
- Capable of analyzing Off-the-Shelf (OTS) software or Software of Unknown Provenance (SOUP) for capabilities and possible validations requirements, in accordance with company safety and quality policies/procedures.
- Authentication and encryption methods, secure data exchange methods.
- Understanding of modern software development tools and Software Configuration Management (SCM).
- Experience using revision control software such as Subversion or SourceSafe, or GitHub.
- Experience with QT/QML integrated development environment
- Experience with ultrasound signal processing concepts or interface a plus.
- Familiarity with various test equipment such as digital oscilloscopes, DVMs, spectrum analyzers, and other common electronic test instruments.
- Risk management analysis experience at least 5 years.
- Experience in relational database development e.g. SQL a plus
- Ability to define problems, to collect data, to understand testing results, to apply statistical methods and write reports with valid conclusions
- Understanding of the FDA and other federal regulatory agencies standards.
- Ability to write clear and thorough design descriptions, test protocols and engineering reports.
- Excellent command of the English language, both written and oral.
- Strong sense of accountability including time management, meeting deadlines, and the organization of multiple projects at the same time.
- Competent engineer in all conventional aspects of the subject matter, functional area, and assignments.
- Needs to have a high sense of urgency and a self-starter that can contribute to the team.
- Strong verbal and written communication skills to include preparation of FDA required documentation.
- Strong interpersonal skills and business acumen.
- Able to lead a process with urgency in high-pressure situations.
- Ability to communicate well with the R&D team.
- Strong verbal and technical writing skills, attention to detail and accuracy.
- Ability to multi-task, use sound personal judgment, reason, and logic.