Automation& Validation- Medical Devices

Fusion Life Sciences Technologies LLC

Santa Clara (CA)

On-site

USD 120,000 - 180,000

Part time

14 days+

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Job summary

A leading company in the biotechnology sector seeks a Senior Robotics Systems Engineer to drive innovation in medical device manufacturing and integration of advanced technologies. Candidates will lead projects in robotics and Industry 4.0 technologies, demanding strong expertise and experience in regulated environments.

Qualifications

Minimum 8 years of industry experience in medical devices, robotics, or regulated engineering environments.
Hands-on experience with robot platforms, embedded systems, and industrial automation is crucial.
Strong understanding of Industry 4.0, IoT protocols, and smart factory solutions is required.

Responsibilities

Lead system engineering design for medical devices, ensuring regulatory compliance.
Drive development of robotic solutions for production, diagnostics, and drug delivery.
Architect and implement Industry 4.0 technologies in medical device manufacturing.

Skills

Robotics

Automation

Industry 4.0

IoT solutions

Medical device product development

Analytical skills

Leadership

Education

Bachelor’s or Master’s in Robotics, Mechanical, Electrical, Biomedical Engineering, or related field

Tools

MATLAB/Simulink

SolidWorks Motion

DOORS

Polarion

Jama

Job description

Senior Robotics Systems Engineer – Healthcare & Industry 4.0

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Job Summary

We are seeking an experienced and innovative Senior Systems Engineer with strong expertise in robotics, autonomous systems, Industry 4.0 technologies, and medical device product development. The successful candidate will work on advanced engineering projects involving the integration of smart manufacturing systems, IoT solutions, and robotic automation into medical device manufacturing or R&D settings.

Key Responsibilities

Lead system engineering design for medical devices by applying robotics, automation, and IoT concepts aligned with industry best practices and regulatory standards.
Drive the development of autonomous systems and robotic solutions for use in production, surgical devices, diagnostics, or drug delivery platforms.
Architect and implement Industry 4.0 technologies, including digital twins, AI/ML-enabled systems, sensor integration, and cyber-physical systems.
Develop and execute verification and validation (V&V) strategies following FDA, ISO 13485, and IEC 60601/62304 standards.
Oversee end-to-end system integration, from concept to deployment, ensuring interoperability across hardware, software, and data layers.
Evaluate new technologies and provide proof of concept (PoC) for emerging trends in smart devices and connected health platforms.
Collaborate with R&D, manufacturing, quality, and regulatory teams to translate requirements into scalable and compliant systems.
Define and manage system requirements, specifications, and interface definitions, using tools like DOORS, Polarion, or Jama.
Design robust test plans and protocols for complex electromechanical and robotic systems, ensuring performance under clinical and industrial conditions.
Apply system modeling and simulation tools such as MATLAB/Simulink, SolidWorks Motion, or SysML for design verification.
Ensure compliance with international standards (FDA 21 CFR Part 820, ISO 14971, ISO 13485, MDR) during development and implementation.
Mentor junior engineers and support cross-functional training on smart systems and Industry 4.0 tools.
Interface with vendors and external technology partners to evaluate and integrate sensors, PLCs, HMI, and cloud-based platforms.
Document system architecture, design decisions, and risk assessments in line with Good Documentation Practices (GDP).
Lead root cause investigations and corrective actions for system failures or non-conformances in lab and production environments.
Develop cybersecurity risk mitigations for IoT and cloud-connected devices in alignment with FDA premarket and postmarket guidance.
Drive continuous improvement initiatives using Lean, Six Sigma, and data-driven process automation.
Support technology transfer from development to manufacturing, ensuring process robustness and scalability.
Utilize Agile methodologies and collaborate in sprint-based development cycles for faster iteration and innovation.
Maintain awareness of industry trends and regulatory updates to continuously enhance product performance and compliance.

Qualifications & Skills

Bachelor’s or Master’s in Robotics, Mechanical, Electrical, Biomedical Engineering, or a related field.
Minimum 8 years of industry experience in medical devices, robotics, or related regulated engineering environments.
Hands-on experience with robot platforms (e.g., UR, KUKA, ABB), embedded systems, and industrial automation.
Strong understanding of Industry 4.0, IoT protocols, digital thread, and smart factory solutions.
Proficient with system engineering tools and V-model development lifecycle.
Experience in IEC 60601, ISO 14971, ISO 13485, FDA QSR, EU MDR preferred.
Familiarity with software architecture, sensors, actuators, and control systems.
Excellent analytical, documentation, communication, and leadership skills.

Seniority level