Are you prepared to join a cutting edge, dynamic team that is innovating and disrupting the med-tech field? Sanuwave is hiring motivated, passionate, high preforming individuals to support the commercialization of its newly approved FDA devices! If you think you are ready to join a face-paced, growing company with high energy and tremendous potential upside, then consider joining us at Sanuwave.
SANUWAVE Health, Inc. is an emerging leader in the development and commercialization of a high-energy focused, shock wave technology that is used in devices for the repair and regeneration of bones, muscles, tendons and skin, and for the separation of solids and fluids in non-medical systems. Headquartered in Suwanee, GA, SANUWAVE designs, manufactures, markets and services its industry leading products for worldwide distribution.
We are looking to fill an open Software Engineer position.
This position focuses on discovery, invention, design, development, support and documentation of developing technologies for medical and non-medical devices uses. At times the incumbent will receive technical guidance on unusual or complex problems, but independently will determine and develop approaches to 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 FDA/QSR design controls for the development of medical device electronics and embedded software.
- Consult with supervisor concerning unexpected or unusual problems and developments.
- Perform as a staff consultant on a 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.
- Other duties may be assigned.
Knowledge, Skills and Abilities
- Mastery of theoretical and practical fundamentals in computer science and software engineering, as well as experimental engineering techniques
- 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.
- Embedded systems development experience and ARM processor development
- 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
- 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.
- Strong verbal and written communication skills to include preparation of FDA required documentation.
- 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.
- A fast learner and capable of analytical thinking.
- 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.
- 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 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.
Qualifications (Experience, Education, Licenses and Certification)
- Bachelor’s or Master’s degree in Engineering
- Minimum of four years’ of related experience in the medical device industry.
- The employee should be able to travel up to 10% of time when required.
SANUWAVE is an Equal Opportunity Employer.
Please email your resume to email@example.com and include the title of the job in the subject line.
Qualified applicants will be contacted.