Company Description SARACA is a global engineering R&D services company supporting more than 25 Fortune 500 customers across MedTech, Aerospace, Rail, Automotive, Semiconductor, Defense, and Farm industries. The organization is ISO 13485 certified and has extensive experience with all classes of medical devices, including embedded software, UI/UX, mechanical, systems, and product testing. SARACA’s team of 400+ engineers and management consultants brings deep expertise in standards such as IEC 62304, EU MDR, and a wide range of MedTech regulatory and scientific documentation. With a strong global presence, SARACA addresses complex business and engineering challenges for clients worldwide. The company is an equal-opportunity employer that fosters a culture of innovation, continuous learning, and customer-centric growth.
Position: Hardware Engineer III
Location: Remote
Duration: 6–12+ Months Contract
Start Date: Immediate
Background Check: Mandatory
Key Responsibilities:
• Support embedded hardware design, development, testing, and verification activities for medical devices.
• Perform electrical hardware design verification and validation testing.
• Conduct IEC 60601-1 basic safety testing and EMI/EMC compliance testing.
• Develop test strategies, test plans, protocols, and detailed test reports.
• Perform MRI testing activities for implantable medical devices.
• Support product sustenance engineering, including EOL component replacement analysis, component selection, and BOM lifecycle verification.
• Maintain engineering documentation and support FDA and ISO compliance requirements.
• Collaborate with global cross-functional engineering teams.
Required Skills:
• 15+ years of hardware engineering experience.
• Strong experience with Class II and Class III medical devices.
• Cardiac Rhythm Management (CRM) device experience preferred.
• Expertise in electrical hardware verification testing.
• Experience with EMI/EMC testing and IEC 60601-1 compliance.
• Knowledge of FDA regulations and ISO 13485 documentation.
• Experience with product sustenance, PLM activities, and component obsolescence management.
• Hands-on experience with oscilloscopes, spectrum analyzers, and other electronic test equipment is a plus.
Education:
Bachelor’s Degree in Electrical Engineering or Electronics & Communication Engineering.