Medical Device Testing Jobs in Raleigh, NC (NOW HIRING)

About Us

Founded in 1908, Merz is a successful, family-owned specialty healthcare company with a rich history. As a leading global aesthetics business, our award-winning portfolio of injectables, devices, and skincare products empowers healthcare professionals to enhance confidence through aesthetic medicine. Our purpose is to fuel confidence by helping people look better, feel better, and live better. We believe you do not have to choose between living life and making a living. Live your best life with Merz Aesthetics.

A Brief Overview

The Senior Electrical Engineer will lead the design, development, and analysis of electronic hardware and embedded firmware for both new and existing products within the R&D Product Development organization. This role requires deep expertise in mixed-signal PCBA design, embedded C/C++ firmware development, and system-level engineering. You will work hands-on in the lab to prototype, debug, and validate designs, while collaborating closely with internal hardware/software teams and external design partners to meet technical requirements, project schedules, and cost targets. Key responsibilities include developing system and subsystem requirements, translating them into robust hardware and firmware architectures, and executing verification and validation activities to ensure design compliance. Strong analytical and troubleshooting abilities are essential for solving complex electrical and embedded system challenges. Experience with IEC 60601 electrical safety and EMC standards is required to ensure products meet all regulatory and quality expectations

What You Will Do

• Verification Testing:
  • Complete system integration and verification test planning using high-level verification test plans.
• Electrical Root Cause Analysis:
  • Lead root cause investigations for product quality issues and implement correction plans
• Electrical Engineering:
  • Properly plan and execute scheduled electrical and firmware work packages collaborating with internal and external design resources to meet project milestones.
  • Delivering electrical and embedded products in a timely fashion with integrity and meeting all applicable standard for medical device quality.
  • Provide electrical and firmware engineering support ensuring current and new products meet Medical Device safety requirements such as IEC 60601 and other Medical Device standards.
  • Ensure duties are completed according to Merz SOPs and enhance necessary SOPs to improve efficiency and quality.
  • Responsible for electrical engineering design, development and support of products, sub-assemblies, board level circuits with a strong emphasis on digital and some analog based circuits containing HIFU amplifiers, linear regulators and buck power supplies.
  • Write and develop associated firmware designs to support hardware functionality. Experience in FPGA and Micro Controller designs and able to write in Verilog and VHDL code.
  • Responsible for verifying electrical and firmware design requirements through engineering analysis and testing.
  • Write and conduct engineering studies for root cause analysis on product enhancements and failures.
  • Provide broad electrical and firmware engineering technical expertise through various phases of product life cycle.
  • Provide electrical and firmware engineering analysis, feasibility reports and studies to assist the product development team.
  • Maintain/improve existing product designs in support of Manufacturing activities.
  • Follow design control procedures and enhance existing procedures as needed.

Minimum Requirements

• Bachelor of Science (B.S.) in Electrical Engineering, Systems Engineering or a related field.
• 5+ years of engineering experience in the medical device industry and/or highly regulated engineering environments
• 7+ years of proven experience in mixed signal designs utilizing FPGAs
• Exposure to software development practices and IEC 62304

Preferred Qualifications

• Master's Degree of engineering experience in the medical device industry and/or highly regulated engineering environments

Technical & Functional Skills

• Demonstrated ability to author and manage systems, sub-assembly and board level requirements and specifications in a highly methodical and organized manner
• Experience with mixed signal technology designs
• Good understanding of high-speed PCB layout considerations such as parasitic, crosstalk isolation, power supply noise, grounding, and EMI consideration
• Familiarity with common manufacturing methods, both for electrical and mechanical and components
• Experience with Altium Designer, OrCAD, Cadence Allegro, PADs schematic and layout tools or equivalent
• Strong comprehension of risk management and risk analysis techniques, consistent with ISO 14971, applied to medical devices
• Thorough understanding of verification strategy and test planning.
• Experience in Verilog for FPGA designs.
• Experience with Altera, Xilinx or Lattice FPGA development environments.
• Experience with engineering analysis tools such as MATLAB and Signal Integrity tools, Hyperlinx or other similar tools.