Principal Software Engineer - Medical Devices

500M - D&D Department - M Full Time Durham, NC, US

4 days ago Requisition

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 ensuring 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.

• 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%).

• 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,…