Software Engineer (Contract) – Medical Devices

Talented Software Engineer (Contract) needed to partner with Gilero's Durham, NC team where we help bring life-enhancing products to market efficiently and effectively. Seeking an independent contractor to help provide specialized skills during an increase in our workload for software engineering. In this role, you will be working on various embedded software projects for medical device and drug delivery applications. 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

Location: Durham, NC

Responsibilities:

• Contributes 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.
• 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.
• 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 test methods and 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.
• Contributes to developing software engineering tools and processes and trains others to use those systems.
• Identifies technical opportunities and generates work for themselves within their assigned project teams.
• Defines objectives, participates in, and oversees quality of output for large or complex
• projects.
• Contributes to solving open-ended problems and tasks with a high level of decision-making.
• Formulates and develops detailed project deliverables with some 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 is aware of industry trends.
• Supports business development efforts as a SME to potential customers and providing input on engineering estimations.

Skills/Qualifications:

• BS in Engineering or equivalent technical degree.
• Willing to work in the Durham, NC office 4 days per week.
• 5+ years relevant experience.
• Proficiency with software development in C/C++ for microcontrollers / microprocessors.
• Experience developing embedded software for medical devices.
• Proven track record of fully developing embedded software and architectures.

Working knowledge of the following areas is preferred:

• Integrating firmware and application software systems.
• Various software tools including Gitlab, Visual Code, Eclipse, Docker, JIRA, JAMA.
• Programming RISC and ARM-based microcontrollers
• Hardware debugging (digital and analog).
• OS coding techniques, IP protocols, interfaces and data management.
• Development drivers and middleware for Linux.
• Software configuration management tools, defect tracking tools, and peer review.
• How to develop products for compliance with FDA 21 CFR Part 820.30, IEC 62304, ISO 14971, ISO 13485 and EU MD.

Personal Attributes:

• Meets Gilero Core Values: 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

Candidates must be legally eligible to work in the US without requiring current or future sponsorship. 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.