The Senior Software Engineer will develop software for products in various stages of the development lifecycle. This includes new product development, updates to support new clinical studies, upgrades to commercial products. In addition, the Software Engineer will work closely with the R&D and Manufacturing teams to help develop test fixtures for design verification, incoming or in-process inspection of critical components or subassemblies, and other projects requiring electro-mechanical system support. The position may be required to perform all, or a combination of the following essential responsibilities as determined by necessity.

This role is located at the Company’s Woburn, MA office, we require 4 days on-site, one remote.

Essential Duties and Responsibilities:

· Design, develop, and test embedded software for medical devices and related equipment/fixtures from conception/requirements to design, implementation, and testing

· Work on software design, coding, and validating software, supporting verification and validation testing, and ensuring that all product development conforms to design specifications and coding standards for medical devices

· Effectively utilize best practices to design, document, and test medical device software for new and existing products

· Collaborate with other R&D engineers, and with Quality, Regulatory, Marketing and

Manufacturing to ensure that designs meet technical, regulatory, and manufacturing requirements in compliance with company policies.

· Develop requirements, development plans, test plans and risk management solutions.

· Create novel design solutions that expand the business’s intellectual property

· Participate in product design reviews.

· Prototype and characterize new sensors, actuators, and control schemes.

· Work closely with other engineers, technicians, and team members to troubleshoot complex

technical issues with a methodical, data-driven approach

· Demonstrated competence to handle a wide range of software development

· Must have excellent analytical skills, with very strong attention to detail.

· Ability to work both independently and in a collaborative team setting.

· Ability to manage both day-to-day operations as well as project work in a fast-paced

environment.

· Must demonstrate a keen attention to detail and timelines.

· Must be self-motivated with project management and problem-solving skills.

· Excellent written and verbal communication skills.

· Excellent organizational skills

· Ability to handle multiple projects

· Other duties as assigned.

Education and/or Experience:

· Experience in developing C/C++ solutions for embedded applications, C# GUI applications,

Python, Android.

· Experience with real-time operating systems (RTOS) software development and bare-metal

microprocessor development, ability to understand complex embedded systems

· Strong familiarity with current development tools (IDEs, debuggers, unit test frameworks)

· Strong root cause analysis skills, including use of tools such as an oscilloscope, logic analyzer, digital voltmeter

· Effective verbal and written communication skills to communicate at multiple levels of an

organization

· Effective writing skills for preparing requirements documents, design documents, test protocols, test reports, and other engineering and medical device documentation

· Ability to organize and judge priorities, to develop and execute on timelines

· Self-motivation to keep up with current software development advances using new technologies

· Demonstrated knowledge of medical device design controls (21 CFR Part 820) and experience

with software development for medical devices and IEC 62304 compliance is preferred

· Knowledge of the principles of quality software engineering as described by software lifecycle development processes that are consistent with ISO, IEEE, or other FDA recognized standards is preferred

· Familiarity with control systems and cybersecurity is desirable

· Demonstrated competence to handle a wide range of software development

· Must have excellent analytical skills, with very strong attention to detail.

· Ability to work both independently and in a collaborative team setting.

· Ability to manage both day-to-day operations as well as project work in a fast-paced

environment.