Software Engineer II

OrthAlign, Inc., a Smart Technologies, growing medical device company, has an immediate opening for a Software Engineer. This role is responsible for the design, development, and validation of software for sensor-based technology solutions to advance orthopedic navigation on next-generation medical devices. This challenging role is comprised of a broad range of responsibilities including evaluating user needs, creating software requirements, developing software solutions to address technical and user requirements, integrating solutions into embedded hardware platforms, and testing implementations for efficacy and reliability. Working closely with hardware, algorithm, biomedical, and quality engineers to improve upon existing products and release new products to market, this role works with technologies such as microprocessors, LCDs, sensors, Bluetooth, the Android Operating System, Android based applications, and sensor-based navigation algorithms.

This role is in-office, not remote, and is based in Irvine, California. 

You will:

• Develop software solutions for medical device applications, including user interfaces, sensor data collection, navigation algorithms, and communication with other devices.
• Write clean, efficient, and well-documented code in languages such as Java.
• Work with hardware and firmware engineers to integrate software into embedded hardware platforms.

• Prepare and maintain software documentation for regulatory submissions.
• Participate in software validation and verification activities, including unit testing, integration testing, system testing, and performance validation.
• Support software risk management activities.
• Lead software engineering projects as defined by management in support of new and existing products.
• Mentor and provide technical leadership to others.
• Assess failure modes and conduct technical risk analysis.
• Support the design and implementation of product improvements targeting reliability, quality, and performance.
• Stay current with software engineering best practices, emerging technologies, and trends in the medical device industry.
• Suggest and implement improvements to development processes, coding practices, and tools.
• Contribute to the continuous improvement of the software development lifecycle, including code reviews, design reviews, and peer mentoring.
• Build and integrate backend services (full stack development preferred).

You need:

• BS degree in embedded systems, computer science, or electronics engineering and 0 - 3 years' experience working in software development, preferably medical device
• Proficiency with Android application development experience required.
• Experience writing and debugging top level source code required.
• Experience with web development frameworks, ideally React on the front end.
• Experience with object-oriented programming and algorithms required.
• Hands on experience with Bluetooth (BLE and/or Classic) communication on Android - device discovery, pairing, and data exchange.
• Experience with IoT platforms preferred.
• Experience designing or consuming RESTful APIs/HTTP endpoints.
• Experience drafting software requirements and performing software verification and validation activities preferred.
• Ability to support the development & execution of verification, validation & qualification protocols.
• Strong proficiency using MS Office Suite (e.g., Word, Excel, PowerPoint).
• Strong debugging, optimization, and performance analysis skills.
• Knowledge of cloud platforms (AWS, Azure, or GCP) and CI/CD pipelines is a plus.
• Familiarity with database technologies, both SQL and NoSQL.
  
• Excellent written and verbal communication skills.
• Ability to work as a collaborative team member as well as independently.
• Applies sound judgment when making decisions and communicating with peers and management.
• Identifies and resolves problems in a timely manner, gathering and analyzing information skillfully.
• Experience successfully leading software engineering projects of moderate scope to completion.
• Knowledge of FDA, ISO, GMP and design control and software development regulations is preferred.
• Willingness and capability to take ownership of projects and drive them to a successful conclusion.
• Strong analytical and organizational skills to solve complex problems.

We offer:

• Competitive compensation including bonus and equity
  
• Opportunities for career advancement
• Full benefits package including 401(k) and voluntary benefit offerings
  
• An evolving, engaging culture and workplace
• Nominated by our employees as a Top Place to Work in Orange County!

It is an exciting time at OrthAlign - make your next career move with us!