Staff Biomedical Engineer

BIOTRONIK SE & Co.KG; Lake Oswego (OR); Hybrid; USD 100,000 - 140,000; Full time

Job summary

Micro Systems Engineering, Inc. in Lake Oswego, Oregon, is seeking a Staff Biomedical Engineer to join our team focused on implantable medical device software.

The role emphasizes ensuring designs meet specifications for low-power embedded real-time applications and demands strong verification leadership. The candidate will develop test designs, review requirements, and guide the Software Verification team.

Qualifications

• 5 years of experience performing software verification or software development.
• 5 years of experience developing medical device software through writing code.
• 5 years of experience with Microsoft Visual Studio in a highly regulated environment developing automated tests with C#.
• 5 years of experience utilizing Git and Azure DevOps Source Control.
• 5 years of experience with software lifecycle processes in a highly regulated environment (including FDA, ISO, and other regulatory bodies).
• 2 years of experience performing software testing for the BLE protocol.
• 2 years of experience utilizing the HP ALM tool.
• 2 years of experience utilizing the Windows Power Shell scripting tool.
• 1 year of experience administering Azure DevOps tools.
• 1 year of experience utilizing the Aras (Software) Product Lifecycle Management tool.
• 1 year of experience serving as technical lead in software project management (e.g., estimating efforts, creating project plans, tracking the project progress).

Responsibilities

• Ensure that MSEI biomedical device design conforms to product specifications of extremely low power embedded real time applications (3%).
• Develop test design documents and code (3%).
• Generate and execute appropriate level of verification for each work product (3%).
• Review test procedures generated by associate software verification engineers, as technical team lead (10%).
• Review requirements specification and design and development work (5%).
• Generate protocols, guidelines, and training sessions for the Software Verification team on proper verification test designs, as technical team lead (10%).
• As technical team lead, work with internal contacts within a team, cross functional team contacts, as well as contacts with external vendors to discuss issues and lead scheduling coordination and task progress, with direction from management (15%).
• Follow structured product development lifecycle in the medical device regulated environment (5%).
• Serve as verification lead on projects and generate resource schedules, guidelines, protocols, and training sessions for the software verification team (35%).
• Remain current in relevant software development processes, techniques, and tools (3%).
• Remain current in the latest advances and developments in the application area for which the company generates products (3%).
• Foster a culture of continuous process improvement (5%).
• Approximately 10% of time will involve travel domestically or internationally per year.

Skills

Software verification

Software development

C#

BLE testing

Technical lead

Tools

Microsoft Visual Studio

Git

Azure DevOps

HP ALM

Windows PowerShell

Aras PLM

Job description

Requisition ID62643-Posted09/09/2026- Posting Country (1) - Work Location (1) -Engineering-Undefined-Full-time-Mid-Career-MST

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.

Please join us as:

Staff Biomedical Engineer

Micro Systems Engineering, Inc.

Staff Biomedical Engineer in Lake Oswego, Oregon

Job Duties:

Ensure that MSEI biomedical device design conforms to product specifications of extremely low power embedded real time applications (3%).
Develop test design documents and code (3%).
Generate and execute appropriate level of verification for each work product (3%).
Review test procedures generated by associate software verification engineers, as technical team lead (10%).
Review requirements specification and design and development work (5%).
Generate protocols, guidelines, and training sessions for the Software Verification team on proper verification test designs, as technical team lead (10%).
As technical team lead, work with internal contacts within a team, cross functional team contacts, as well as contacts with external vendors to discuss issues and lead scheduling coordination and task progress, with direction from management (15%).
Follow structured product development lifecycle in the medical device regulated environment (5%).
Serve as verification lead on projects and generate resource schedules, guidelines, protocols, and training sessions for the software verification team (35%).
Remain current in relevant software development processes, techniques, and tools (3%).
Remain current in the latest advances and developments in the application area for which the company generates products (3%).
Foster a culture of continuous process improvement (5%).

Approximately10% of time will involve international or domestic travel per year.
This is a hybrid position, requiring 2 days onsite in Lake Oswego per week.

• 5 years of experience performing software verification or software development.
• 5 years of experience developing medical device software through writing code.
• 5 years of experience working with Microsoft Visual Studio in a highly regulated environment developing automated tests with C#.
• 5 years of experience utilizing the tools Git (Global Information Tracker) and Azure DevOps Source Control.
• 5 years of experience with software lifecycle processes in a highly regulated environment (including FDA, ISO, and other regulatory bodies).
• 2 years of experience performing software testing for the Bluetooth Low Energy (BLE) protocol.
• 2 years of experience utilizing the HP (Hewlett Packard) Application Lifecycle Management tool.
• 2 years of experience utilizing the Windows Power Shell scripting tool.
• 1 year of experience administering Azure DevOps tools.
• 1 year of experience utilizing the Aras (Software) Product Lifecycle Management tool.
• 1 year of experience serving as technical lead in software project management (e.g., estimating efforts, creating project plans, tracking the project progress).

All education, experience, and training may be gained concurrently. Applicants must be U.S. workers (includes U.S. citizens, permanent residents, foreign nationals granted temporary residence under one of the 1986 legalization programs, refugees, and asylees).

Working hours: Full-time

Job ID: 62643

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, nationaloriginor 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.