We are growing our team and looking for an Embedded Software Verification Engineer to play a key role in our Biotronik NRO Business Unit . You will report to the Director of Software and be responsible for testing to ensure the quality of our embedded medical device software. These subsystems are part of a larger ecosystem that includes implantable devices, mobile apps, and web-based platforms. You will collaborate with yourquality assurance peer on the external devices side, utilizing shared processes and tools. To excel in this role, you should have a strong background in test automation with C#, experience working with embedded system emulators, an understanding of real-time software written in C/C++, experience developing test automation libraries, and familiarity with requirements tracing processes typical of regulated industries.

Your Responsibilities

• Maintain test automation libraries and tools.
• Generate and maintain relevant QA documentation.
• Generate and present ideas for continuous process improvement.
• Technology selection to meet evolving QA challenges.
• Review work products of team members.
• Maintain and communicate the group’s project schedule.

Your Profile

Education / Experience Requirements

• BS Degree in computer science, electrical engineering, or related field.
• 4 years of graduate-level coursework and/or experience in software development or QA.
• 3 years of experience using C#.
• 3 years of experience with development environments, debugging tools, git, test automation, and defect tracking tools.
• 2 years’ experience in medical device or similarly regulated industry.
• 2 years’ experience with real-time software written in C/C++.
• Strong written and verbal skills.

Additional Preferred Knowledge, Skills, Abilities

• Experience with the implementation of a large body of regression tests.
• Experience with real-time systems, low-power micro-controller platforms.
• Experience with Bluetooth peripherals.
• Experience with embedded system simulators, and protocol simulators.
• Azure Devops (aka TFS) platform, pipelines, git repos, project management boards
• Ability to troubleshoot electronics.
• Experience with the concepts and development of Software as Medical Device (SaMD) and Mobile Medical Applications (MMA), as defined by FDA is a plus.
• Experience with FDA, 21CFR820, ISO 13485, IEC 62304, and regulatory submission of Class III Medical Devices is a plus.

Location

This position is in Lake Oswego, Oregon. We have a flexible hybrid policy, which needs to balance the need to interact with specialized test equipment. This position involves complex lab setups, which can partially be replicated in a home office setting.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, and photocopiers.

Physical Requirements

This is a largely sedentary role. While performing the duties of this job, the employee is regularly required to use hands and fingers to handle, feel or operate objects, tools or controls, and reach with hands and arms. The employee is frequently required to talk and hear. All reasonable accommodations will be made.

About MSEI

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.

EEO Commitment

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.

If you're passionate about building high-quality software for life-changing medical devices , we’d love to hear from you!