Gilero, A Sanner Group Company

Compensation

Full Description

Talented Engineer with a background in embedded firmware needed to join Gilero's team where we help bring life-enhancing products to market efficiently and effectively. Gilero is a trusted partner for medical and drug delivery device development, offering expertise in design, development, and manufacturing solutions. We have a passion for innovation and a commitment to excellence with a broad range of projects and technical expertise. Join our team and contribute to improving lives worldwide. In this role, you will be responsible for leading embedded software project activities for medical device and drug delivery applications for a variety of our clients. Responsibilities: • Acts as technical lead/architect and advisor 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. • Plans, authors, and executes protocols for design verification and validation. • Analyzes test data, interprets results, and formulates conclusions. • Maintains the Design History File (DHF) and ensures 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 project teams. • Defines and leads objectives and oversees the quality of output for large or complex projects. • Solves open-ended problems and tasks with a high level of decision-making and some 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 with industry trends. • Supports business development efforts as a SME to potential customers and leading multi- • disciplinary engineering estimations. • Establishes a proven track record of building trust and rapport with new clients. • Acts as a mentor demonstrating strong leadership skills. • 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. • Willing to work 3-4 days a week in the Durham, NC office. • 8+ 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. • Proficiency with software development in C/C++ for microcontrollers / microprocessors. • Proficiency with integrating firmware and application software systems, preferred. • Proficiency with various software tools including Gitlab, Tessy, Docker, JIRA, JAMA, preferred. • Proficiency with programming RISC and ARM-based microcontrollers, preferred. • Proficiency with hardware debugging (digital and analog), preferred. • Proficiency with 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. • Working knowledge of how to develop products for compliance with FDA 21 CFR Part 820.30, 21 CFR Part 4, ISO14971, ISO 13485, and EU MDR, preferred. Personal Attributes: • Meets Gilero Core Values: • Collaboration and Innovation of 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: • Applicants must be permanently authorized to work in the United States without the need for employer sponsorship now or in the future. • Gilero does not offer sponsorship for employment authorizations (work visas). • We are an E-Verify employer and confirm work authorization for all new hires. Why work at Gilero? Founded in 2002, Gilero, a Sanner Group company, is an international contract engineering firm that specializes in the design, development, and manufacturing of novel medical devices and drug delivery products. At Gilero, we are proud of the culture we have built that directly reflects our values of excellence, integrity, innovation, and collaboration. Motivated by our purpose to benefit people and improve patient outcomes, our team continues to grow at a rapid pace. US locations include Carlsbad, CA; Chicago, IL; as well as NC locations in Raleigh, Durham, Greensboro, and Pittsboro. You will enjoy an annual bonus plan, Medical (3 BCBS plans to choose from), Guardian dental and vision, company-provided life insurance, short-term and long-term disability, 401(k) with a match the first month you start with a zero-vesting period, and access to LinkedIn learning for personal and professional development.