Talented and experienced medical device Software Engineer needed to join Gilero’s Carlsbad, CA 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 as a Senior Software Engineer 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.

SKILLS/QUALIFICATIONS:

• US citizen or Green card holder
• Willing to work 3 days per week in the Carlsbad, CA office
• BS in Engineering or equivalent technical degree.
• 5+ years relevant medical device experience.
• Proficiency with software development in C/C++ for microcontrollers / microprocessors.
• Experience developing embedded software for medical devices, preferred.
• Proven ability to lead a product development program from concept to market release, preferred.
• Proven track record of fully developing embedded software and architectures, preferred.

Working knowledge of the following areas is preferred:

• Integrating firmware and application software systems.
• Various software tools including Gitlab, Tessy, 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, 21 CFR Part 4, ISO14971, ISO 13485 and EU MDR.

• Acts as technical lead 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 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.
• Establishes a proven track record of building trust and rapport with new clients.
• Acts as mentor demonstrating strong leadership skills.
• Participates in recruitment activities including interview panels.
• Travel will be required, as necessary (typically less than 5%).