Principal Software Engineer - Medical Devices

GILERO • Durham, NC

6d • Onsite

About The Position

Sanner America is seeking a Principal Software Engineer with embedded firmware experience to join its Durham, North Carolina team. The company develops and manufactures medical devices, drug delivery systems, and healthcare packaging. In this role, you will lead embedded software projects and apply advanced software expertise to medical device and drug delivery applications, primarily Class I and Class II electromechanical devices. You will contribute across the full product development lifecycle, from initial concept through market release, working with customers, vendors, and internal teams in a fast-paced, collaborative environment.

The role combines technical leadership, hands-on embedded software development, systems integration and verification, product and process risk work, regulatory documentation, customer communication, and mentoring. You will also contribute to business development, recruitment, training, and the development of software engineering tools and processes. Travel may be required as necessary, typically less than 10%.

Requirements

• Bachelor of Science in Engineering or an equivalent technical degree.
• 12+ years of relevant experience.
• 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 or microprocessors.
• Ability to pass a pre-employment background check.
• Permanent authorization to work in the United States without employer sponsorship now or in the future.

Nice To Haves

• Experience developing embedded software for medical devices.
• Expertise and experience integrating firmware and application software systems.
• Expertise using software tools including GitLab, Tessy, Docker, JIRA, and JAMA.
• Expertise programming RISC- and ARM-based microcontrollers.
• Proficiency in digital and analog hardware debugging.
• Expertise in OS coding techniques, IP protocols, interfaces, and data management.
• Proficiency developing drivers and middleware for Linux.
• Proficiency with software configuration management tools, defect tracking tools, and peer review.
• Working knowledge of agile methodologies and continuous integration/continuous deployment (CI/CD) practices.
• Working knowledge of cybersecurity principles and considerations in medical device software development.
• Proficiency developing products for compliance with FDA 21 CFR Part 820.30, 21 CFR Part 4, ISO 14971, ISO 13485, and EU MDR.

Responsibilities

• Act as technical lead and thought leader throughout the product development lifecycle, from initial concept to market release, for new medical devices, primarily Class I and Class II electromechanical devices.
• Design, develop, and test embedded firmware.
• Serve as an architect and/or software technical lead for product development projects.
• Lead and participate in systems and integration testing, unit testing, and code reviews.
• Analyze and improve the efficiency, stability, and scalability of system resources.
• Coordinate activities with internal and external software developers.
• Lead and participate in writing product and customer requirements, design and phase reviews, product and process risk assessments, root cause investigations, and corrective action planning.
• Author and advise on test plans and protocols for design verification and validation.
• Analyze test data, interpret results, and formulate conclusions.
• Maintain the Design History File (DHF), ensuring documents are complete, accurate, current, and compliant with regulations.
• Own and manage the development and improvement of software engineering tools, processes, and systems, and train others who work within or manage those systems.
• Identify technical opportunities and generate work for themselves and across the company.
• Define and lead objectives and oversee the quality of output for large or complex projects.
• Solve open-ended problems and tasks with a high level of decision-making and autonomy.
• Formulate and develop detailed project deliverables with minimal management oversight.
• Communicate technical risks and proposed solutions clearly and directly to customers.
• Source and interface with third-party vendors.
• Act as a subject matter expert lead in one or more areas, remain current on industry trends, and contribute to those trends.
• Participate in seminars or other speaking engagements on behalf of the company.
• Support business development as a subject matter expert for potential customers and lead multidisciplinary engineering estimations.
• Refer new business to the company based on established trust and rapport in the industry.
• Serve as a role model and mentor, and coordinate and deliver group training sessions.
• Participate in recruitment activities, including interview panels.
• Travel as necessary, typically less than 10%.

Benefits

• Annual bonus plan.
• Three BCBS medical plans.
• Dental and vision coverage.
• Company-provided life insurance.
• Short- and long-term disability coverage.
• Paid maternity and parental leave.
• 401(k) match beginning the first month after hire, with no vesting period.
• Access to LinkedIn Learning, with over 21,000 courses and certifications for personal and professional development.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal