Senior Embedded Software Manager – Medical Devices

Gilero; Durham, Northern (NC, KY); Hybrid; USD 140,000 - 190,000; Full time

Benefits offered by this job

Annual bonus

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401(k) with match

Paid parental leave

Paid time off

LinkedIn Learning

Career growth

Job summary

Gilero, a Sanner Group company, seeks an experienced Software Development Manager to lead the embedded software team for medical device and drug delivery applications. You will drive software architecture, lifecycle processes, and regulatory compliance (IEC 62304) while collaborating with electrical, hardware, and systems engineers.

Responsibilities include hands-on firmware design, design controls, V&V, and preparing documentation for premarket submissions.

Qualifications

• Bachelor's degree in Computer Science, Engineering, or related technical field.
• Minimum 10 years of embedded software development experience for medical devices.
• Working knowledge of IEC 62304, ISO 13485, and FDA regulations.

Responsibilities

• Lead the embedded software team across full development lifecycle.
• Define and implement software processes aligned with regulatory standards.
• Hands-on firmware development and UI design as needed.
• Develop software architecture strategy for scalable, reliable systems.
• Oversee design controls, requirements, risk assessments, and V&V reports.
• Prepare software documentation for premarket submissions.

Skills

Embedded software

Leadership

Regulatory compliance

C/C++/Python

CI/CD

Education

Bachelor's degree in CS/Engineering

Tools

GitLab

Tessy

Docker

JIRA

JAMA

Job description

Gilero, a Sanner Group company, seeks an experienced Software Development Manager to lead the embedded software team for medical device and drug delivery applications. You will drive software architecture, lifecycle processes, and regulatory compliance (IEC 62304) while collaborating with electrical, hardware, and systems engineers.

Responsibilities include hands-on firmware design, design controls, V&V, and preparing documentation for premarket submissions.