Staff Software Development Engineer

The Staff Software Development Engineer is a senior technical contributor responsible for the architecture, design, development, verification, and maintenance of software used in implantable spinal cord stimulation systems and supporting clinical applications. This role provides technical leadership across software development efforts while ensuring compliance with medical device regulations and quality standards. The Staff Engineer collaborates closely with cross-functional teams including Systems Engineering, Electrical Engineering, Firmware, Quality Assurance, Regulatory Affairs, Clinical Affairs, and Product Management to develop safe, reliable, and effective software solutions that improve patient outcomes.

PRIMARY JOB RESPONSIBILITIES

• Lead the design and development of software for medical devices, clinician programmer applications, patient applications, and supporting cloud or desktop systems.
• Define software architecture and technical direction for complex projects spanning multiple software components.
• Develop high-quality, maintainable, and well-tested software following established software engineering principles and coding standards.
• Participate in product planning, requirements analysis, system design, risk analysis, implementation, verification, and product release activities.
• Ensure software development complies with applicable quality system regulations and standards, including FDA Quality System Regulation and other applicable standards.
• Perform technical reviews of software requirements, architecture, source code, test plans, and design documentation.
• Mentor software engineers by promoting engineering best practices, code quality, design patterns, and continuous improvement.
• Collaborate with systems, firmware, hardware, and clinical engineering teams to integrate software with implantable neurostimulation devices.
• Support cybersecurity, software reliability, and performance initiatives throughout the product lifecycle.
• Investigate field issues and implement corrective and preventive actions when required.
• Contribute to software process improvements, development tools, automated testing, and continuous integration pipelines.
• Participate in design reviews, hazard analyses, and risk management activities to ensure patient safety.
• Provide technical guidance during regulatory submissions and product audits.

REQUIRED QUALIFICATIONS

• Bachelor's degree in Computer Science, Software Engineering, Computer Engineering, or related technical field.
• 6+ years of professional software development experience.
• Extensive experience designing and developing complex software applications using modern programming languages such as C#, C++, Kotlin.
• Experience developing software using object-oriented design principles and software architecture patterns.
• Strong understanding of Agile software development methodologies.
• Experience with version control systems such as Git.
• Strong analytical, debugging, and problem-solving skills.
• Excellent written and verbal communication skills.
• Demonstrated ability to lead technical initiatives without direct managerial responsibility.

PREFERRED QUALIFICATIONS

• Master's degree in Computer Science, Engineering, or related field.
• Knowledge of NoSQL
• Experience developing software for regulated medical devices.
• Knowledge of IEC standards, and FDA software guidance, and cybersecurity requirements for medical devices.
• Experience with Bluetooth Low Energy (BLE), embedded communications, or implantable medical device interfaces.
• Experience with automated testing frameworks, CI/CD pipelines, and static code analysis tools.
• Familiarity with cloud-connected medical systems and secure data communication.

Key Performance Expectations

• Deliver high-quality software that meets functional, performance, safety, and regulatory requirements.
• Drive technical decisions that improve scalability, maintainability, and reliability.
• Ensure software documentation is complete, accurate, and audit-ready.
• Reduce software defects through design reviews, code reviews, and comprehensive testing.
• Foster engineering excellence by mentoring developers and promoting software best practices.
• Support successful regulatory submissions and product releases through technical expertise and documentation quality.

TRAVEL REQUIREMENTS

Must be able to travel internationally and domestically, less than 15% of the time.

WORK ENVIRONMENT

If onsite, this role is based in a temperature controlled professional office setting, which may include an office or cubicle with quiet to moderate noise level. If remote, the work environment is the employee’s residence. Work may need to be completed on campus in a lab, or manufacturing environment such as clean room or warehouse. Personal protective equipment is required in the clean room and may be needed in a lab. The noise level in the lab, and manufacturing environments are quiet to moderate. The role may travel to vendors, customers, external training, expos, industry or product events, and networking events shifting the work environment.

This position is Hybrid, based in out Lake Oswego, Oregon office.

ABOUT US

Working for Micro Systems Engineering, Inc. (MSEI) means joining an elite team to work on some of the most exciting challenges in medical technology today. We are a pioneer in developing innovative implantable medical device technologies and devices that save and enhance the quality of life for millions of individuals living with cardiovascular and chronic neurologic pain disorders. With more than 40 years of experience in design and manufacturing of active implantable medical devices, our continuing success is based on our company’s core values - innovation, quality, reliability, integrity, teamwork, and undisputed expertise - thus enabling us to inspire confidence and trust in physicians and patients worldwide. We are continually looking for talented engineers, scientists, and professionals to share in our mission.

Micro Systems Engineering, Inc. is an equal opportunity employer. In accordance with applicable law, the company prohibits discrimination based on race, color, religion, creed, gender, pregnancy or related medical conditions, age, national origin or ancestry, physical or mental disability, sexual orientation, genetic information, uniformed service or any other consideration protected by federal state and local laws. Our commitment to equal opportunity employment applies to all persons involved in our operations and prohibits unlawful discrimination by any employee.