Firmware Engineer (on-site)

THE OPPORTUNITY: Firmware Engineer, Full Time, On-siteIf 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 noninvasive approach to treat rheumatoid arthritis and other chronic and acute inflammatory disorders. Our SecondWave MINI device uses proprietary ultrasound technology on a wearable, personalized stimulation platform, giving patients and their physicians a new option for treating multiple health conditions.SecondWave consists of a diverse, multi-disciplinary team that is focused on bringing this new technology 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 multiple 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. 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 AND DUTIES:Must have medical device experience.Takes primary responsibility for the development of medical device firmware and software, 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 software 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 software.Work with clinical and commercial development teams to generate and implement user requirements.Author documentation to support software 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.User interfaces (e.g. displays, switches, etc.)Device drivers and firmwareSignal Processing code / AlgorithmsMobile application developmentTravel up to 15%Other duties as assigned. QUALIFICATIONS:Bachelors in Software Engineering, Electrical Engineering, Computer Science, or equivalent experience. Masters preferred.4+ years experience in architecture, design, and verification and validation of software for medical instrumentation systems and devicesExperience bringing medical devices through product development process in accordance with design control processes and international standards.Familiarity and adherence to software development process in a regulated environment, such as per IEC62304, IEC60601Understanding of the FDAs Quality Systems Regulations 21 CFR Part 820 and AIMDD/EUMDR requirements for design control.Utilization of Microsoft development environment and tool suiteExperience in VHDL, Verilog, and System VerilogExperience working with FPGAs and/or SOMs for testing, verification of concepts, and implementation of algorithmsKnowledge of code and algorithmic optimization based off hardware and device functional constraintsAdvanced and current knowledge of software engineering methods and practices, such as code reviews and static analysis, unit test execution, integration testing, system verification and validation.Software and hardware tool validation experience.Working knowledge of FDA and EUMDR guidance on Cyber security with implementation experience in quality system and medical device productWorking knowledge of risk management processesMobile development, UI/UX engineering a plus.Strong organizational and time management skillsStrong interpersonal communication and presentation skills (verbal, written, and visual)Creative problem solving and analytical skillsMotivated team player experienced with working in diverse teamsAbility to conduct technical activities with minimal directionSelf-starter initiative and mindset for continuous learningPHYSICAL 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. PAY AND BENEFITS:Pay Range: $130,000-150,000 base salary; depending on qualifications/experience; Equity compensation to be providedFLSA Status: Full Time ExemptSecondWave Systems offers a comprehensive benefits package that includes: Medical, dental, and vision insurance Short- and long-term disability insurance Employee Assistance Program Company paid and Voluntary Life insurance Aflac Paid company holidays Vacation and sick time SIMPLE IRA with 3% company match Opportunities for advancementTO APPLY:Apply via our Careers site. Check us out at 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 during normal work hours and as needed to meet business requirements are encouraged to apply; there is no relocation allowance.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.No agencies, please.Notice to Recruiters/Staffing Agencies:Recruiters and staffing agencies should not contact SecondWave Systems through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees. We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file. SecondWave Systems receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between SecondWave Systems and such organization and will be considered unsolicited and SecondWave Systems will not be responsible for related fees.Fraud AlertTo all candidates: your personal information and online safety are a top priority for us. At SecondWave Systems, HR only direct candidates to apply through our official career page at and HR will always contact you using the domain of secondwaveus.com. We will never request payments, ask for financial account information or sensitive information like social security numbers. If you are unsure if a message is from SecondWave Systems, please act with caution.
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