Senior Biomedical Software Verification Lead (Hybrid)

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

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.