Senior Embedded Software Lead, Medical Devices

Sanner America (formerly Gilero); Durham (NC); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Annual bonus plan

BCBS medical plans

Dental and vision coverage

Life insurance

401(k) with company match

LinkedIn Learning access

Job summary

Sanner America in Durham, NC seeks a Principal Software Engineer to lead embedded firmware projects for medical devices. You will architect, develop, and verify complex software across the full lifecycle, coordinating with internal and external teams while ensuring regulatory compliance and high-quality results.

You will mentor others, drive CI/CD practices, and contribute to business development as a technical SME, with travel as needed.

Qualifications

• BS in Engineering or equivalent technical degree.
• 12+ years relevant experience.
• Experience developing embedded software for medical devices, preferred.
• Proven ability to lead a product development program from concept to market release.
• Proven track record of fully developing embedded software and architectures.
• Expertise in software development in C/C++ for microcontrollers / microprocessors
• Expertise and experience integrating firmware and application software systems, preferred.
• Expertise in using various software tools including Gitlab, Tessy, Docker, JIRA, JAMA, preferred.
• Expertise with programming RISC and ARM-based microcontrollers, preferred.
• Proficiency with hardware debugging (digital and analog), preferred.
• Expertise in OS coding techniques, IP protocols, interfaces and data management, preferred.
• Proficiency with development drivers and middleware for Linux, preferred.
• Proficiency with software configuration management tools, defect tracking tools, and peer review, preferred.
• Working knowledge of agile methodologies and continuous integration/continuous deployment (CI/CD) practices, preferred.
• Working knowledge of cybersecurity principles and considerations in medical device software development, preferred.
• Proficiency with developing products for compliance with FDA 21 CFR Part 820.30, 21 CFR Part 4, ISO14971, ISO 13485 and EU MDR, preferred.

Responsibilities

• Acts as technical lead and thought leader throughout the full product development lifecycle from initial concept to release to market of new medical devices; primarily class I and class II electro-mechanical devices.
• Designs, develops, and tests embedded firmware.
• Serves as an architect and/or software technical lead for product development projects.
• Leads and participates in systems and integration testing, unit testing, and code reviews.
• Analyzes and enhances efficiency, stability and scalability of system resources.
• Coordinates activities with other software developers both internal and external.
• Leads and participates in writing product and customer requirements, design and phase reviews, product and process risk assessments, root cause investigations, and corrective action planning.
• Authors and advises on test planning and protocols for design verification and validation.
• Analyzes test data, interprets results, and formulates conclusions.
• Maintains the Design History File (DHF) to ensure documents are complete, accurate, current, and compliant with regulations.
• Owns and manages the development and improvement of software engineering tools, processes, and systems and trains others that are working within and managing those systems.
• Identifies technical opportunities and generates work for themselves and across the company.
• Defines and leads objectives and oversees quality of output for large or complex projects.
• Solves open-ended problems and tasks with a high level of decision making and autonomy.
• Formulates and develops detailed project deliverables with minimal management oversight.
• Communicates technical risks and proposed solutions clearly and directly with the customer.
• Sources and interfaces with third party vendors.
• Acts as subject matter expert (SME) lead in one or more areas and remains current and contributes to industry trends.
• Participates in seminars or other speaking engagements on behalf of the company.
• Supports business development efforts as a SME to potential customers and leading multidisciplinary engineering estimations.
• Refers new business to the company based on established trust and rapport in industry.
• Acts as a role model and mentor; coordinates and delivers group training sessions.
• Participates in recruitment activities including interview panels.
• Travel will be required, as necessary (typically less than 10%).

Skills

Embedded software

C/C++

Medical devices

Leadership

Software architecture

Linux drivers

GitLab

CI/CD

OS concepts

Cybersecurity basics

Education

Bachelor's in Engineering

Tools

GitLab

Tessy

Docker

JIRA

JAMA

Linux development

Job description

Sanner America in Durham, NC seeks a Principal Software Engineer to lead embedded firmware projects for medical devices. You will architect, develop, and verify complex software across the full lifecycle, coordinating with internal and external teams while ensuring regulatory compliance and high-quality results.

You will mentor others, drive CI/CD practices, and contribute to business development as a technical SME, with travel as needed.