Senior Embedded Software Manager – Medical Devices

Gilero, A Sanner Group Company; Durham (NC); On-site; USD 140,000 - 210,000; Full time

Benefits offered by this job

Annual bonus

Medical insurance

Dental insurance

Vision insurance

401(k) with match

Paid parental leave

Paid time off

LinkedIn Learning

Job summary

Gilero, a Sanner Group company, seeks an experienced Senior Embedded Software Leader to drive development of medical device software in our Durham, NC team. You will manage a team of engineers across full lifecycle, collaborate with electrical and hardware groups, and ensure regulatory compliance per IEC 62304.

You will shape software architecture, lead design controls, contribute to premarket documentation, and mentor staff while supporting business development through technical estimations.

Qualifications

• 10+ years in embedded software for medical devices.
• Leadership experience guiding cross-functional teams.
• Regulatory standards knowledge: IEC 62304, ISO 13485, FDA.
• Experience with CI/CD practices.
• Proficient in C/C++/Python and related toolchains.

Responsibilities

• Lead embedded software development lifecycle for medical devices.
• Oversee cross-functional design with electrical and hardware teams.
• Define software processes aligned with regulatory standards.
• Mentor software team and support business development.
• Ensure documentation, traceability, V&V, and releases.

Skills

Leadership/mentoring

Regulatory knowledge IEC 62304

Communication

C/C++/C#/Python

Education

Bachelor’s or higher in Computer Science/Engineering

Tools

Gitlab

Tessy

Docker

JIRA

JAMA

Job description

Gilero, a Sanner Group company, seeks an experienced Senior Embedded Software Leader to drive development of medical device software in our Durham, NC team. You will manage a team of engineers across full lifecycle, collaborate with electrical and hardware groups, and ensure regulatory compliance per IEC 62304.

You will shape software architecture, lead design controls, contribute to premarket documentation, and mentor staff while supporting business development through technical estimations.