Talented Principal Software Engineer with a background in embedded firmware needed to join Sanner America's Durham, NC team. 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.
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.
