Principal R&D Software Engineer
Description
Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.
Description
Position Overview
The Principal R&D Software Engineer will lead technical development of innovative electronic systems to treat peripheral and heart valve diseases, will participate on multiple cross-functional development teams that manage projects from concept through commercialization, and will perform and support a variety of development and engineering activities with primary focus on analog high-voltage circuit design and development.
Essential Job Functions
- Lead the software development for medical device product(s) in full compliance with the company’s Design Control requirements and consistent with FDA, ISO, and MDR requirements.
- Define architecture of software system for next generation product including the development of RTOS/Bare Metal code on embedded processor(s).
- Proficiency in writing code in C/C++ programming languages and understanding assembly language.
- Develop User Interface applications operating system.
- Develop code per IEC/EN 62304 medical device standard.
- Understanding of communications protocols and developing driver for 1 Wire, I2C, SMBUS, SPI (QSPI), UART, and USB communication.
- Proficient in the use of software development tools including compilers, assemblers, emulators, in-circuit debugging tools (IAR, REAL ICE, GDB etc), Oscilloscopes and Logic Analyzers.
- Generate Software Requirement & Design specifications type documents from Product Specifications by decomposing into testable requirements.
- Actively participate in Hazard Analysis, Design FMEA, Firmware Risk Assessment, Risk Control measure in a cross functional team setting.
- Take ownership on development of DV protocols, provide test cases and test coverage for functional testing. Unit testing Integration testing.
- Initiate and conduct software system code reviews.
- Develop documentation per regulatory body guidelines.
- Interface with internal regulatory affairs and assist with submissions.
- Support of medical device company audits processes.
- Understanding of electrical systems and reading schematics.
- Debug/Troubleshoot complex systems and implement fixes.
- Collaborate with HW Engineers to develop and implement design concepts.
- Other duties as assigned.
Requirements
- Bachelor’s Degree in Software/Electrical Engineering with 10+ years’ design and development experience, or a Master’s Degree with 8+ years.
- Experience in generating technical Requirement & design specifications required for Class III medical device products.
- Extensive experience in architecting and developing Software Systems using embedded processors like Renesas, PIC32, STmicro running RTOS/Bare Metal.
- Demonstrated proficiency in C language programming for embedded ARM processors, C++ is a plus/desirable.
- Experience developing application code in C# language for Windows 10.
- Experience with setting up of communications buses between microprocessor subsystems.
- Experience in writing firmware unit test and generating test reports.
- Development of software in disciplined approach using tools for Requirement Management, Version Control and Issue tracking e.g GIT, JIRA and JAMA.
- Proficient in the use of development and debugging tools like compilers, assemblers, In-Circuit-Emulators, Oscilloscope and Logic Analyzers.
- Experience with Cross Compiler toolchains, Linkers and with build configuration files.
- Experience with designing system Architecture based on design patterns.
- Experience with automating software testing using scripting languages e.g. Python, TCL, PERL.
- Effective written and verbal communication skills with all levels of management and organizations.
- Developing software from concept to commercialization while adhering to Software Design Life Cycle process per IEC/EN 62304.
- Ability to work independently in a fast-paced environment while managing multiple priorities.
- Familiarity with Waterfall model, V model, Agile methods in software development.
- Ability to adapt and reprioritize to changing requirements.
- Design experience with FPGA’s using VHDL or Verilog is a plus.
- Experience with lasers and pulse discharge systems a plus.
- Employee may be required to lift objects up to 25lbs.
Exact compensation may vary based on skills, experience, and location.
Benefits
Shockwave Medical offers a competitive total compensation package as well as the following benefits and perks:
Core Benefits: Medical, Dental, Vision, Pre-tax and Roth 401k options with a fully vested match, Short-Term and Long-Term Disability, and Life Insurance, Employer contribution toward Health Savings Account (HSA), Competitive PTO balance
Perks: ESPP, Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards
EEO Employer