Systems Engineer

Stark Pharma Solutions Inc; Pleasanton (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Stark Pharma Solutions Inc is seeking an experienced Systems Engineer based in Pleasanton, CA. You will lead system integration for complex medical devices, focusing on the integration of hardware and software. The ideal candidate has a strong background in systems engineering and experience in regulated environments.

This role requires collaboration across global teams to achieve project objectives. Qualifications include a Bachelor's or Master's degree in a relevant field with substantial integration experience.

Qualifications

• 5-6 years of relevant experience with a Bachelor's degree, or 4+ years with a Master's.
• Proven experience in leading integration activities involving hardware and software.
• Experience in regulated medical device environments preferred.

Responsibilities

• Lead system integration planning and execution across the product lifecycle.
• Define and manage integration strategies, interface requirements, and risk mitigation.
• Coordinate activities across hardware and software.

Skills

Systems Engineering

Integration Experience

Communication Skills

Stakeholder Management

Technical Documentation

Education

Bachelor's or Master's degree in relevant field

Job description

Role: Systems Engineer

Location: Pleasanton, CA

Contract Duration: 12 Months

Position Overview

We are seeking an experienced Systems Engineer to lead system integration activities for complex, regulated medical devices. This role will support both new product development and sustaining engineering initiatives, focusing on the integration of mechanical, electrical, embedded software, mobile applications, wireless technologies, and cloud-connected systems. The ideal candidate will bring strong systems engineering expertise, hands-on integration experience, and the ability to work independently while collaborating with cross-functional teams in a fast-paced medical device environment.

Key Responsibilities

• Lead system integration planning and execution throughout the product lifecycle, from architecture and design through verification, validation, and design transfer.
• Define and manage system integration strategies, interface requirements, integration sequencing, and risk mitigation plans.
• Coordinate integration activities across hardware, embedded software, mobile applications, wireless communication technologies, and cloud-based platforms.
• Support system architecture development, interface management, and requirements allocation across multidisciplinary teams.
• Partner with Systems, Software, Hardware, Quality, Clinical, and Regulatory teams to identify and resolve integration issues through structured root-cause analysis.
• Support system-level verification and validation activities, ensuring traceability, test readiness, and issue resolution.
• Lead technical reviews, communicate integration risks and trade-offs, and provide technical guidance to project teams.
• Ensure compliance with quality systems, design controls, configuration management, and change management processes.
• Collaborate with global engineering teams, vendors, and stakeholders to achieve project objectives and deliverables.

Required Qualifications

• Bachelor's degree in Systems Engineering, Biomedical Engineering, Electrical Engineering, Software Engineering, Computer Science, or a related technical discipline with 5-6 years of relevant experience; OR
• Master’s degree in a related field with 4+ years of relevant experience.
• Proven experience leading system integration activities involving both hardware and software components.
• Strong understanding of system architecture, interface management, and complex system behavior.
• Experience working in regulated product development environments (medical devices preferred).
• Hands-on experience collaborating across software, hardware, and systems engineering teams.
• Knowledge of design controls, configuration management, defect tracking, and change control processes.
• Excellent communication, technical documentation, and stakeholder management skills.
• Ability to work independently and drive projects in a matrixed organization.