As an important member of the company’s Device Development team, the Senior Software Engineer is responsible for embedded and application software activities across multiple projects for the development of electronics-based medical devices.

Device firmware and software application development activities might span across pre-concept through architecture definition, development, verification, transfer, and product manufacturing. The primary activity is the development of device iteration, manufacturing tools, and test equipment.

Other development may include work for the operation of low-power microcontrollers including system-level control and management of device components.

Requires knowledge and a strong background in engineering, scientific, and regulatory aspects of medical devices and previous experience taking Class II or III devices from concept to market.

The ability to work on product development efforts individually and with team members within software, electrical, and mechanical engineering for the development of novel medical devices is important for this role.
 
What you will be doing:
 

• Perform firmware and software development activities from pre-concept to production for FDA-approved medical devices and related fixtures for testing, manufacturing, etc.
• Create, review, and revise software documentation for release per quality system.
• Planning, designing, and refactoring firmware for low-power microcontroller-based devices.
• Software development for the operation of device components such as sensors, LEDs, etc. Create, and deploy software-driven manufacturing and test tools for internal purposes and contract manufacturing organizations.
• Work on complex issues where analysis of data and context requires an in-depth evaluation of variable factors.
• Collaborate with Quality team members to ensure quality standards, procedures, and methods are met and maintained throughout the development cycle.
• Collaborate with internal and external engineers on the incorporation of product development needs, software-driven algorithms, and data processing modules.
• Help drive and manage software project timelines and resource needs for device projects.
• Provide timely updates to the manager on project development status, issues, and discoveries.
• Work with software test staff to ensure proper test plans are created, executed.
• Contribute to device history, risk mitigation, and quality documents of devices moving towards regulatory filings (i.e., 510k, De Novo 510K and PMA).
• Perform other duties as they are identified to support cross-functional teams.

• Minimum BS in SWE, EE, CE, CSE.7 years’ overall experience; 5 years experience in medical devices, preferably drug/device combinations.4 years development in C/C++.Evidence of full medical device life cycle at one company (concept to production).
• Familiarity with architectures for complex electromechanical systems.
• Familiarity with medical standards for engineering design and testing.
• Familiarity with medical ISO/IEC processes such as 13485, 14971, 62304.Have worked to the actual standards, not just company-specific processes.
• Developed products and composed FDA-compliant documentation.
• Experience in project setup for successful testing at V&V stages.
• Ability to work autonomously, handle multiple projects and priorities, and good project management skills.
• Working knowledge of medical device manufacturing requirements and needs.
• Design controls experience with FDA QSR 21 CFR Part 820 and ISO 13485.Strong knowledge of I2C, SPI, UART protocols, and driver development.
• Experience working STM 32-bit Cortex M-processors or similar.
• Strong object-oriented programming and design skills.
• Experience in writing control software (C#/Python) for custom test equipment supporting medical device development.
• Understanding of electronics components, systems, and circuit design.
• Experience configuring, managing, and working with a software revision control solution.
• Document generation and practices for approval of software-driven medical devices.
• Strong mathematical skills and understanding of data processing methods for real-time algorithm deployment.
• Knowledge of Jira, GitHub, Eclipse, Atollic TrueSTUDIO, or similar IDEs.
• Ability to communicate at all levels of the organization and perform/lead with influence.
• Proactive, forward-thinking, and creative with high ethical standards, and leadership skills.
• Ability to influence others to achieve successful outcomes and meet timelines.
• Ability to function efficiently, effectively, and at times independently in a fast-paced, changing environment.
• Strong team player with a mindset aligned with the company’s corporate values.