Senior Electrical Engineer(Onsite)

Stellent IT LLC; Raleigh (NC); Vor Ort; USD 120.000 - 180.000; Vollzeit

Zusammenfassung

Stellent IT LLC seeks a Senior Electrical Engineer to lead hardware and embedded firmware development for medical devices in Raleigh, NC. The role requires mixed-signal PCBA design, embedded C/C++, and lab-based prototyping and testing to meet project timelines and regulatory targets.

You will translate system requirements into robust hardware and firmware architectures, perform verification planning, and collaborate with internal teams and external partners to ensure safety standards like IEC

Qualifikationen

• Bachelor of Science in Electrical Engineering or related field.
• 5+ years in medical device or highly regulated engineering environments.
• Exposure to IEC 62304 and software development practices.

Aufgaben

• Lead design and analysis of hardware and embedded firmware for medical devices.
• Develop system and sub-assembly requirements and architectures.
• Perform verification, validation and risk analyses to ensure design compliance.
• Lead root-cause investigations and implement corrective actions.
• Ensure compliance with IEC 60601 and related medical device standards.

Ausbildung

Bachelor's degree in Electrical Engineering

Master's degree in related field

Tools

Altium Designer

OrCAD

Cadence Allegro

PADS

Jobbeschreibung

Senior Electrical Engineer (Onsite)

Location: Raleigh, NC

Interview: Phone+Skype

Job Description

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
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.
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.
Required for all jobs:
Performs other duties as assigned
Complies with all policies and standards

MINIMUM QUALIFICATIONS

Education

Bachelor of Science (B.S.) in Electrical Engineering, Systems Engineering or a related field.

Work Experience

5+ years of engineering experience in the medical device industry and/or highly regulated engineering environments and 7+ years of proven experience in mixed signal designs utilizing FPGAs and

Exposure to software development practices and IEC 62304

PREFERRED QUALIFICATIONS

Education

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

Physical Requirements

This job requires various physical activities and environmental conditions that employees must be prepared to handle. Key physical requirements include standing, sitting, walking, and bending, with tasks involving repetitive movements and handling objects of different weights, ranging from light (under 5 lbs) to heavy (over 20 lbs). Employees will also need to operate machinery such as computers, copiers, and telephones, and perform tasks requiring manual dexterity and visual acuity. The working environment may expose employees to different temperatures, noise levels, and other conditions like humidity and heights. Sensory requirements include near and far visual acuity, color discrimination, hearing, and speech. Additionally, some roles may involve local, national, or international travel (up to 20%). These requirements ensure that the job is performed effectively while accommodating employees needs in compliance with the Americans with Disabilities Act (ADA).

Travel Requirements

0% - 10%