Medical Device Embedded System Engineer Jobs in Cary, NC

HCR0003189
Title: Senior Electrical Engineer
Location: Raleigh NC
Pay Rate: 50-65/HR on W2
Monday to Friday (On-site required)

Job Summary
The Senior Electrical Engineer is responsible for electrical hardware and firmware design and analysis of current and new systems within the R&D Product Development group. This will be done by organizing and actively working with internal hardware engineering teams and external engineering design partners, meeting schedule timelines, project milestones, and cost targets. A knowledge of electrical hardware design, development, and deployment and embedded firmware is required. Experience in creating and implementing system and subsystem level requirements then performing verification testing of designs. Experience in embedded C/C++ software development and mixed-signal PCBA design in a cross-functional team environment. Ability to effectively plan and implement design from given requirements and ensure design outputs meet the requirements. Experience with IEC 60601 electrical EMC and Safety testing to ensure product complies with quality & regulatory standards.

Responsibilities Description

• 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.
• Complete system integration and verification test planning using high-level verification test plans.
• 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
• Lead root cause investigations for product quality issues and implement correction plans.

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.

Minimum Qualifications

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

Preferred Qualifications
• Graduate degree in Electrical Engineering, Systems Engineering or a related field.

Kindly share resume with answers:
Q1: How many years have you worked in medical devices or highly regulated industries?
Q2: How many years of electrical engineering experience do you have
Q3: How many years of FPGA experience, which platforms have you used? ( 1: Client/Altera 2: AMD/Xilinx 3: Lattice)