Compliance Group Inc ยท 19 hours ago
Senior System Engineer
San Diego, CA
Contract
Hybrid
Mid, Senior Level
3+ years expCompliance Group Inc is focused on developing innovative solutions in the medical device sector. The Senior Systems Engineer will lead the design and development of wearable medical devices, overseeing systems engineering activities and collaborating with cross-functional teams to ensure project deliverables are met.
AnalyticsComplianceData IntegrationMedicalSoftware
Hiring Manager
Javed Khan
Responsibilities
Serve as a key member of a cross-functional project team consisting of electrical, software, mechanical, manufacturing, and quality engineers to achieve project deliverables
Lead system definition tasks such as generating user needs, product requirements, and use-case descriptions
Contribute to system development by defining system and subsystem architectures
Identify and document system hazards, failure modes, and risk mitigations
Work with the technical centers of excellence domain subject matter experts and suppliers in the assessment, selection, integration, and qualification of key components and subsystems
Serve as technical consultant for integration, subsystem and system verification activities creating plans, protocols and reports, as necessary
Create and maintain traceability among design input, design output, design verification and validation, and risk management artifacts to ensure completeness and fully traceable design history file
Support the preparation of proposals, project plans and estimates, and present information and status to leadership and other stakeholders
Serve as technical consultant for software development deliverables, such as design/architecture documents, requirements and failure mode analysis
Participate in Agile ceremonies, such as Program Increment (PI) Planning, Retrospectives, Inspect and Adapt
Provide guidance and support to junior engineers, promoting knowledge sharing and professional development
Qualification
Required
Bachelor of Science in an Engineering (Systems, Biomedical, Electrical, Computer Science, Mechanical) discipline
A minimum of 3 to 7+ years of experience working as a Systems Engineer or with systems engineering responsibilities in a multidisciplinary project team environment
2+ years of experience in leading a cross-functional development team
Demonstrated expertise in Systems Engineering practices such as requirements management, design trade-off and cost-benefit analysis, hazards and risk assessments
Experience with long term R&D development programs (concept/feasibility, development, commercialization)
Experience in application lifecycle management tools (i.e. Polarion ALM, Helix ALM, Doors)
Experience with root cause analysis and troubleshooting
Experience writing verification plans, protocols and reports in a regulated industry
Experience with data analysis (Minitab, JMP, or MatLAB)
Proficient with Medical Device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls)
Excellent project team skills; experience and capability working collaboratively under a Quality Management System (QMS), as part of a cross-functional team, such as development, verification/validation, manufacturing, marketing, clinical, regulatory and quality experts
Ability to communicate at multiple levels of an organization
Ability to organize and judge priorities in a dynamic environment
Preferred
Master of Science degree is desired; System Engineering training and/or certification is a plus
Formal training in established Systems Engineering concepts
1-2 years of experience in Model-based Systems Engineering
1-2 years of experience working in Agile software development projects. Agile certification is a plus
Experience with change orders within a Product Lifecycle Management (PLM) tool (Arena PLM)
Demonstrated skills in developing and introducing innovative FDA regulated medical devices in the drug delivery market
Experience in reliability engineering practices such as reliability/data-based performance modeling, performance testing, prediction, HALT and HASS
1-2 years of experience working with 3rd party partners/vendors
Domain expertise in one or more of the following: security, cloud, communication (BLE, NFC), circuit design
Six sigma training / certification
2-3 years of experience in cloud technologies such as AWS and solid understanding of microservices, REST and HTTP
General understanding of communication, mobile technology, IoT (Internet of Things), GDPR; a strong plus
Experience with SolidWorks or Pro-Engineer
Experience with software tools and coding (C++, JAVA, Android UI)
Company
Compliance Group Inc
Compliance Group is a Quality Compliance solutions provider based in Illinois, US with offices in NJ, the UK and India.
201-500 employees
H1B Sponsorship
Compliance Group Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2020 (1)
Funding
Current Stage
Growth StageRecent News
2025-11-05
2025-10-19
Company data provided by crunchbase