What are the responsibilities and job description for the Electrical / Product Engineer (Medical Devices) position at SARACA?
Company Description
SARACA is a global engineering R&D services company, partnering with over 25 Fortune 500 customers. Specializing in industries such as MedTech, Aerospace, Automotive, and Defense, SARACA is an ISO 13485 certified leader in medical device design and development. The company has unique expertise in regulatory compliance, including IEC 62304 standards and EU MDR, as well as deep proficiency in embedded software, UI/UX, and product testing. With over 400 highly skilled engineers and consultants, SARACA is dedicated to delivering innovative solutions to clients worldwide. As an equal-opportunity employer, SARACA cultivates a culture of innovation and continuous learning to drive success and growth for its clients in their industries.
Role Overview
Seeking an experienced Electrical / Product Engineer with a strong background in medical devices to drive product enhancements, design changes, and validation activities.
This role focuses on electrical system design, continuous improvement (CIP), and regulatory compliance, ensuring high-quality, cost-effective, and efficient product performance.
Key Skills
Medical Device Product Engineering
Electrical Design & System Architecture
Continuous Improvement (CIP Projects)
Validation (IQ/OQ/PQ), DVT Testing
Regulatory Compliance (FDA, GMP)
Supplier Management & Change Control
Testing, Protocols & Documentation
Responsibilities
Lead Continuous Improvement (CIP) initiatives for cost and performance optimization
Manage design changes, supplier transitions, and component substitutions
Develop project plans, budgets, and feasibility assessments
Execute engineering testing, validation, and design reviews
Ensure compliance with regulatory and quality standards