Gilero, A Sanner Group Company · 1 day ago
Senior Systems Engineer - Medical Devices
Carlsbad, CA
Full-time
Onsite
Senior Level
5+ years expGilero is a leading medical device design, development, and manufacturing partner. We are seeking a highly skilled Senior Systems Engineer to lead and contribute to the development of complex medical devices and combination products, ensuring compliance with regulatory and quality standards.
ManufacturingMedical DevicePharmaceuticalProduct Design
No H1B
U.S. Citizen OnlyHiring Manager
Tricia (Grabfelder) Lucas, MBA
Responsibilities
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
Provides expertise in various Systems Engineering principles including user and stakeholder need definition; requirements definition; risk management, product architecture, configuration management, traceability, change management, and reliability
Plans systems engineering projects by identifying appropriate system development lifecycles
Develops product development strategies for large or complex systems integrations
Generates system architecture definitions, integrations, development viewpoints, and models
Manages the system architecture and relates it to the design throughout the lifecycle
Defines requirements hierarchy and how it relates to verification and validation planning
Performs functional system decompositions to solve complex design challenges
Prepares detailed component and assembly drawings. 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 systems 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 the 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%)
Qualification
Required
BS in Engineering or equivalent technical degree
Work onsite in the Carlsbad, CA office four days per week
5+ years relevant experience
Experience developing electro-mechanical medical devices
Proven ability to lead a product development program from concept to market release
Working knowledge of system modeling tools and methodologies (e.g., UML, SysML)
Working knowledge of working in both agile and waterfall methodologies
Proficiency with SolidWorks or other 3D CAD (Computer Aided Design) modeling software
Working knowledge of requirements management software (e.g., Jama, Polarion, Doors)
Working knowledge of developing products for compliance with IEC 60601 for electrical safety and for software development
Working knowledge of developing products for compliance with FDA 21 CFR Part 820.30, 21 CFR Part 4, ISO14971, ISO 13485 and EU MD
Meets Gilero Core Values: Collaboration, Innovation, Excellence, 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
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
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