Principal Software Engineer - 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

Talented Principal Software Engineer with a background in embedded firmware needed to join Sanner America’s Durham, NC team. Sanner America (previously known as Gilero) is a trusted partner for medical and drug delivery device development and healthcare packaging, offering expertise in design, development, and manufacturing solutions. With a passion for innovation and a commitment to excellence, we help bring life-enhancing products to market efficiently and effectively. Join our team and contribute to improving lives worldwide. In this role you will lead embedded software projects and apply high-level software knowledge and skills for medical device and drug delivery applications.

If you thrive in a fast-paced, collaborative environment and like ensuing high-quality outcomes working with customers, vendors, and internal teams, this is the opportunity for you. As part of the Sanner Group, we share a global culture built on collaboration, transparency, agility, and shared success, united by one purpose: Protecting Health.

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/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.

Personal Attributes

• Demonstrates and consistently supports Sanner America’s Core Values of Collaboration, Innovation, Excellence, and Integrity.
• Productive in a fast-paced, entrepreneurial environment.
• Commits to excellence and quality service to external and internal customers.
• Adheres to established policies and procedures, while contributing to continuous improvements.

Eligibility To Work

• Ability to pass a pre-employment background check.
• Applicants must be permanently authorized to work in the United States without the need for employer sponsorship now or in the future.
• Sanner America does not offer sponsorship for employment authorizations (work visas).
• We are an E-Verify employer and confirm work authorization for all new hires.

Why Sanner America?

Headquartered in Durham, North Carolina, Sanner America is the North American business of the Sanner Group and an end-to-end partner for medical devices, drug delivery systems, and healthcare packaging. Carrying forward the Gilero legacy of more than two decades of medical device design, development, and manufacturing, our teams take products from concept to commercialization. Our culture is built on collaboration, transparency, agility, and shared success, united by the Sanner Group purpose: Protecting Health. US locations include Carlsbad, CA; Chicago, IL; and Durham, Greensboro, and Pittsboro, NC, with additional operations in Mexico.

Sanner America offers an annual bonus plan; three BCBS medical plans; dental and vision coverage; company-provided life insurance, short- and long-term disability; paid maternity and parental leave; a 401(k) match beginning the first month after hire with no vesting period; and access to LinkedIn Learning, with over 21,000 courses and certifications for personal and professional development.

Become part of a team motivated by compassion and a shared commitment for making a meaningful impact on patients, caretakers, and consumers everywhere!