Sr. Embedded Software Engineer

Main Purpose of the Role

The Sr. Embedded Software Engineer applies an interdisciplinary, collaborative approach to plan, design, develop and verify system software. Has advanced level of knowledge in programming languages such as C, C++, C# or Python. Creates, modifies & designs for complex problems and is able to execute all stages of the software development lifecycle. Has good business knowledge and exceptional technical skills. Communicates effectively to both internal teams and external customers. Provides technical guidance to less experienced engineers.

Main Responsibilities

• Lead software development, verification and validation efforts; responsible for on-time delivery of high-quality embedded software that meets budgetary and regulatory objectives.
• Implement approved design control procedures for software development in accordance with FDA guidelines.
• Lead discovery and development of key breakthrough solutions in support of future products.
• Techical leadership of embedded software development processes, including mentoring and technical guidance.
• Confirm system and component capabilities by designing test methods, testing properties, and documenting results.
• Provide technical support for all phases of the medical device software lifecycle, including developing tools for testing, manufacturing or analysis.
• Interface with notified body to support product conformance to medical device software and safety standards (IEC 62304 and IEC 60601).
• Prepare standard reports/documentation/presentations to communicate results to various teams including executive staff.
• Work cooperatively with Quality, Regulatory, Marketing, and Manufacturing teams.
• Work with external suppliers and manufacturers to create, test, and support approval of new systems.
• Interface and build long term relationships with physicians/customers/suppliers/coworkers.
• Lead technical teams in the accomplishment of software design and maintenance activities.
• Collaborate with electrical engineers on electrical requirements, design, testing, system bring-up and reviews.

Education & Experience

• At least 5 years of relevant experience in software engineering or a master’s degree in a related field and 3 years of relevant experience.
• Bachelors degree + 10 years experience in engineering or related field.
• Advanced level ability to conduct thorough data analytics & implement data-driven solutions.
• Knowledge of practical embedded systems design, embedded firmware, communication protocols, motors, RFID, and sensors technology as well as the ability to apply appropriate methods and techniques.
• Expert level experience in one or more product development disciplines (e.g. microprocessor based systems; brushless motors; sensor technologies; embedded software; RFID; Communications protocols; user interfaces).

Preferred Qualifications

• At least 7 years of relevant experience with a bachelor’s degree in a related field or 5 years of relevant experience with a master’s degree in a related field, medical preferred.
• Advanced level ability to conduct thorough data analytics & implement data-driven solutions.
• Experience with analog and digital circuit design.
• Detailed understanding of IEC 62304 and IEC 60601-1 medical software and safety standards; knowledgeable in designing and testing compliant systems.
• Experience designing and implementing CI/CD and HIL (Hardware In the Loop) pipelines for embedded projects.
• Experience using AI to draft requirements and other documentation, write unit tests, perform code reviews, and refactor code.
• Technical proficiencies in addition to software engineering and active in engineering clubs or organizations.

Pay

The base pay for this position is $78,000.00 – $156,000.00. In specific locations, the pay range may vary from the range posted.