Company Description SARACA is a global engineering R&D services company serving 25+ Fortune 500 customers across industries including MedTech, Aerospace, Rail, Automotive, Semiconductor, Defense, and Farm equipment. The organization is ISO 13485 certified and has extensive experience with all classes of medical devices, covering embedded software, UI/UX, mechanical, systems, and product testing. SARACA brings unique expertise in IEC 62304, EU MDR, clinical and performance evaluation reports, and scientific writing for MedTech. With a technically strong team of 400+ engineers and management consultants, SARACA delivers solutions to complex business problems through onsite and offsite projects worldwide. SARACA is an equal-opportunity employer that promotes innovation, continuous learning, and partnership-focused growth for its customers.
Position: Senior Hardware Engineer – Medical Devices
Location:Tarrytown, NY (Onsite)
Experience: 10+ years
Key Responsibilities
- Lead hardware design, development, and sustaining engineering activities for medical devices.
- Design and review analog, digital, and mixed-signal hardware.
- Work with MCUs, FPGAs, sensor interfaces, and embedded hardware.
- Design and evaluate power electronics, including battery-powered systems and DC-DC converters.
- Support high-speed interfaces including Ethernet, USB, SPI, I2C, and CAN.
- Lead/review PCB designs with consideration for DFM, DFT, Signal Integrity (SI), and Power Integrity (PI).
- Support CAPA, NCR, change control, and component obsolescence activities.
- Evaluate and qualify alternate components and suppliers.
- Lead hardware verification and validation (V&V) activities.
- Perform and support dFMEA, pFMEA, and sFMEA.
- Maintain Requirements Traceability Matrix (RTM) and hardware documentation.
- Support compliance with IEC 60601-1, IEC 60601-1-2, ISO 14971, and ISO 13485.
- Support FDA regulatory requirements and medical-device product development.
- Support manufacturing transfer, sustaining engineering, supplier activities, and cost optimization.
- Work with Windchill, Agile PLM, or similar product lifecycle management systems.
- Collaborate with R&D, Quality, Regulatory, Manufacturing, and other cross-functional teams.
Required Qualifications
- Bachelor’s degree in electrical engineering, Electronics Engineering, or related field.
- 10+ years of medical device hardware development experience.
- Strong analog/digital/mixed-signal hardware experience.
- Experience with MCU/FPGA/sensor interfaces.
- Experience with power electronics and battery-operated devices.
- Strong PCB design, DFM/DFT, SI/PI, and high-speed interface experience.
- Experience with hardware V&V and risk/FMEA activities.
- Knowledge of IEC 60601-1/-1-2, ISO 14971, and ISO 13485.
- Experience with CAPA, NCR, change control, component qualification, and obsolescence.
- Experience supporting manufacturing transfer and sustaining engineering.
- Experience with Windchill or Agile PLM is highly desirable.
Preferred Qualifications
- IVD / clinical diagnostics experience.
- VAVE / should-cost experience.
- Safety and EMC experience.
- Supplier qualification experience.
- Agile/Scrum experience.
- Strong experience working in regulated medical-device environments.
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About SARACA (Our Company): www.saracasolutions.com
- SARACA Solutions is a global IT and engineering R&D services company specializing in product development, regulatory compliance, and digital transformation. It serves Fortune 500 clients across industries like medical devices, life sciences, automotive, and aerospace. SARACA offers end-to-end solutions from concept to commercialization.