Gilero, A Sanner Group Company · 4 days ago
SR or Staff Embedded Firmware Engineer - Medical Devices
Carlsbad, CA
Full-time
Onsite
Senior Level, Lead/Staff
$130K/yr - $180K/yr
8+ years expGilero, a Sanner Group company, is an international contract engineering firm specializing in medical devices and drug delivery products. They are seeking a talented Engineer with a background in embedded firmware to lead software project activities for medical device applications, contributing to life-enhancing products.
ManufacturingMedical DevicePharmaceuticalProduct Design
No H1B
Hiring Manager
Tricia (Grabfelder) Lucas, MBA
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%)
Qualification
Required
BS in Engineering or equivalent technical degree
8+ years relevant experience
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
Maintains the Design History File (DHF) and ensures documents are complete, accurate, current, and compliant with regulations
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
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%)
Preferred
Experience developing embedded software for medical devices, preferred
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
Benefits
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
Access to LinkedIn learning for personal and professional development
Company
Gilero, A Sanner Group Company
Gilero offers end-to-end device design, development and contract manufacturing in the medical and pharmaceutical industries.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
$4.49M2024-09-25Acquired
2021-05-14Series Unknown· $4.49M
Leadership Team
Ted Mosler
Chief Executive Officer
Recent News
Triad Business Journal
2025-01-01
2024-01-20
Company data provided by crunchbase