THE OPPORTUNITY: Firmware Engineer (on-site), Full TimeIf you want to accelerate your career in an entrepreneurial environment that continues to re-invent itself in all the right ways...move this job to the top of your list and apply today!THE COMPANY:At SecondWave Systems, we have developed a novel non-invasive device-based therapy to treat rheumatoid arthritis (RA). Our solution provides an alternative to existing treatments which carry high costs and often undesirable side effects, while providing relief from the debilitating symptoms of RA.SecondWave consists of a diverse, multi-disciplinary team that is laser-focused on bringing its therapy to patients with quality and speed. As a fast-growing startup, we move quickly and approach each day with both focus and flexibility. We expect new challenges, attack them with confidence and creativity, and find new opportunities within them. We each wear many hats and enjoy taking on new responsibilities and growing into new areas. If you thrive in this kind of environment, then we look forward to speaking with you.SecondWave Systems is intrigued by, and inspired to hire, a skilled firmware engineer with a core can do attitude, a vision of what can be, instead of what has been and who wants to build on a history of hard work, ethics and pursuit of excellence in every aspect of their daily work. If that describes you, keep reading!SUMMARY:We are looking for an experienced, hands-on Firmware Engineer who is a key contributor and project lead in the development of firmware and software for SecondWaves therapeutic ultrasound products. The successful candidate must have a proven track-record in firmware development for medical devices.The ideal candidate will play a critical role in designing, developing, testing, and maintaining firmware for embedded systems (including microcontrollers and FPGAs). This position requires a strong foundation in programming, hardware interaction, and problem-solving skills to ensure the seamless integration of firmware with hardware components. The Firmware Engineer will work closely with cross-functional teams, including hardware engineers, software developers, and product managers, to deliver high-quality, efficient, and reliable solutions. The Firmware Engineer will be an integral part of the multi-disciplinary team and will execute design efforts related to new product development projects, through all phases of the project lifecycle including definition, conceptualization, design execution and documentation, design verification, and production release. This position involves design of both embedded and application software for medical devices working in small product development teams (2-5 people). This is a technical contributor role. The role spans the development life-cycle from overall software system architecture and design, software requirements development, code development and testing, documentation, and test tool validation.REQUIREMENTS:Must have medical device experience.Takes primary responsibility for the development of medical device firmware for both microcontrollers and FPGAs, including conceptualization, development of specifications, architectural and algorithmic design, implementation, test, verification and validation, and field deployment.Define functional needs and design requirements based on user needsGenerate appropriate design documentationParticipate and drive selection of tools, creation of policies (SOPs, WIs), and methods to facilitate structured firmware development, appropriate controls, and verification / validation efforts. Ensure that the established tools, policies, and methods are used and followed consistently by employees and outside resources.Execute testing in lab environment towards design verification and validation, including protocol generation, testing, and report writing.Ensure adherence to internal design controls as well as domestic and international regulatory standards for product firmware.Work with clinical and commercial development teams to generate and implement user requirements.Author documentation to support firmware design and risk management activities and preside over version control.Create and maintain technical documentation, including firmware design specifications, user manuals, and release notes.Provide prototyping support for early-stage development work on a project basis.Manage development tasks within an Agile development lifecycleSupport the team and product through cycles of integration, system verification, and compliance testing.Provide ongoing support for firmware updates and feature enhancements.Design and execute rigorous verification and validation processes to ensure firmware meets functional, performance, and compliance standards for reliable operation.Other duties as assigned. QUALIFICATIONS:Education: Bachelors degree in Electrical Engineering, Computer Science, or equivalent experience (Masters preferred).Experience:7+ years in software architecture, design, verification, and validation for medical devices.Familiarity with the full product development lifecycle, including design control and international standards (e.g., IEC 62304, IEC 60601).Proven experience with FDA QSR (21 CFR Part 820), AIMDD/EUMDR, and medical device cybersecurity implementation.Embedded programming in C; experience with C#, VHDL/(System)Verilog is a plus.FPGA/SBC development for testing, concept verification, and algorithm implementation.Algorithm optimization for hardware and device constraints.Tools & Skills:Expertise with Microsoft development tools, Python, and MATLAB (preferred).Knowledge of modern software engineering practices (e.g., code reviews, static analysis, unit testing, system V&V).Digital signal processing and filter design.Firmware and hardware tool validation experience.Mobile application development and UI/UX engineering (preferred).Soft Skills:Strong organizational, time management, and communication skills (verbal, written, and visual).Creative problem-solving, analytical skills, and a collaborative team-player mindset.Self-starter with initiative and a passion for continuous learning.Other:Hands-on experience with device drivers, user interfaces (e.g., displays, switches).Ability to work with minimal supervision.Ability to travel up to 15%.PHYSICAL DEMANDS:The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may enable individuals with disabilities to perform the essential functions.The incumbent typically works in an office environment and uses a computer, telephone, and other office equipment as needed to perform duties. The noise level in the work environment is typical of that of an office.Incumbent may encounter frequent interruptions throughout the workday.The employee is regularly required to sit, talk, or hear; frequently required to use repetitive hand motion, handle or feel, and to stand, walk, reach, bend or lift up to 20 pounds. BENEFITS:Medical, Dental, and Vision insuranceShort- and Long-Term Disability insuranceLife insuranceAflac14 paid company holidaysVacation and sick timeSIMPLE IRA with 3% projected company matchOpportunities for advancementTO APPLY:Apply via our Careers site. Check us out at www.secondwaveus.comIf you are in growth-mode and you are seeking the next big challenge to advance your career, we hope to hear from you! Tell us why you are interested in this position and your desired salary in your cover letter. Include your resume, answer a few questions, then click submit. This position will remain open until filled.Applicants must be currently authorized to work in the United States on a full-time basis. This company does not sponsor applicants for work visas.Local applicants or those who can report to work on a punctual basis in St Paul, MN or State College, PA during normal work hours and as needed to meet business requirements are encouraged to apply; there is no relocation allowance. Remote candidates who check all the boxes may be considered.EOE: Minorities/Females/Veterans/Disability. SecondWave Systems reserves the right to alter, change, modify and/or terminate this job posting at any time without advance notice, or obligation, to any party. recblid 8hs7msx1rwmk06jtwjcoi06ymufye0