Senior Electrical Engineer, Advanced Development

A Brief Overview

The Senior Electrical Engineer is responsible for electrical hardware design with emphasis on ultrasonic applications and analysis of current and new systems within the R&D Advanced Development group. The role independently leads defined electrical engineering workstreams and coordinates the technical contributions of internal hardware engineering teams and external engineering design partners, meeting schedule timelines, project milestones, technical requirements, quality objectives, and cost targets. Knowledge of Electrical hardware design, development, and deployment of ultrasonic based medical systems is required.This position will apply electrical engineering principles for medical device designs, and be responsible for electrical engineering of new and current systems in the R&D Advanced Development team. This role requires the ability to set priorities based on project and business needs and work effectively in a team environment to ensure product compliance for quality & regulatory standards, adherence to system level requirements, reliable designs, cost containment, and project timelines. The role facilitates technical discussions, builds alignment among internal and external stakeholders, and provides technical guidance and mentoring to less-experienced engineers.

What You Will Do

• Electrical Engineering:
  
  • Electrical engineering design, development and support of advanced development prototypes, sub-assemblies, and board level circuits with a strong emphasis on analog & RF based circuits including amplifiers, linear & switching power supplies, mixed-mode analog/digital converters, and microprocessor-based systems.
  • Lead the electrical design and integration of assigned products, subsystems or major technical workstreams from concept and feasibility through design verification and transfer readiness. Establish the technical approach, coordinate engineering activities, identify dependencies and ensure that electrical designs satisfy system-level requirements.
  • Provide engineering analysis, feasibility reports, and studies to assist advanced development projects.
  • Provide necessary engineering tools, equipment, parts, etc. across various cross-functional efforts. Provide broad electrical. engineering technical expertise through various phases of product life cycle.
  • Serve as a technical advisor to cross-functional project teams and guide the resolution of complex electrical, system-integration and product-performance issues.
  • Provide electrical engineering support ensuring current and new products meet Medical Device safety requirements such as IEC 60601 and other Medical Device standards.
  • Translate system, user, safety, regulatory and business requirements into electrical design requirements, architecture decisions, interface definitions and verification strategies. Assess how proposed design decisions affect product performance, reliability, manufacturability, serviceability, cost and lifecycle objectives.
  • Review electrical designs, analyses and technical documentation produced by internal engineers and external design partners. Provide technical direction, identify gaps and ensure that conclusions and recommendations are supported by appropriate engineering evidence.
• Innovation:
  
  • Develop, design, build, and test innovative concepts and solutions which align with the needs of the clinic, patient, and business.
  • Apply internal and external engineering best practices, emerging technologies, competitive or market information, clinical needs and lessons from existing products to identify improvements to products, engineering methods and development processes.
  • Guide cross-functional teams in converting ambiguous clinical, product or business needs into testable engineering concepts and actionable development plans.
  • Present technical options, trade-offs and recommendations to project stakeholders, anticipate questions or objections and build agreement on the preferred technical approach.
• Verification Testing:
  
  • Lead system integration and verification test planning using high-level verification test plans.
  • Guide engineers and external partners in diagnosing and resolving complex integration or verification issues. Use test data, engineering analyses, risk information and input from multiple disciplines to determine root causes and recommend corrective actions.
• Test Methods:
  
  • Develop, review, and approve test plans, procedures, methods, and data analysis approaches as it relates to technical requirements and specifications. Validation of the test tool or setup is usually required.
  • Guide the development and troubleshooting of complex or novel test methods where established precedents are insufficient. Evaluate alternative approaches and select methods based on technical risk, accuracy, repeatability, efficiency and regulatory expectations.

Minimum Requirements

• Bachelor of Engineering (B.E.) in Electrical Engineering, Systems Engineering or a related field.
• 5+ years of engineering experience in ultrasound system design, ultrasound-based medical device development, or other highly regulated engineering environments with demonstrated ultrasound system experience.
• 2+ years of proven experience in analog design completing board level and product designs with analog circuits. Specific experience in board-level power supplies, power amplifiers, high power frequency generation synthesizers, filters, and wave shaping.
• 1-2 years of full development lifecycle experience (concept to commercialization) with at least one medical device.
• 1-2 years of experience with medical devices with integrated software, hardware, and firmware.
• 1-2 years of experience with IEC 60601-1 and -2 Medical Device Safety testing
• 1-2 years of experience with FDA QSR (21 CFR 820), ISO 13485, ISO 14971 Required

Preferred Qualifications

• Master's Degree of engineering with experience in the medical device industry and/or highly regulated engineering environments
• Experience collaborating with design partners/contract engineering firms to design and develop a medical device.
• Experience with oversight of contract test agencies, including problem resolution, for standardized testing.
• Exposure to software development practices and IEC 62304.

Technical & Functional Skills

• Demonstrated ability to understand systems, sub-assembly and board level requirements and specifications in a highly methodical and organized manner.
• 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.
• Experience with circuit modeling tools such as LTSpice or equivalent.
• Thorough understanding of verification strategy and test planning.
• Experience with engineering analysis tools such as MATLAB and Signal Integrity tools, Hyperlinx or other similar tools.
• Experience with analog board level design for frequency generation, power amplifiers, harmonic filter suppression, wave shaping, and mixed signal technology designs.
• Familiarity with acoustic modeling and simulation tools, such as COMSOL or other FEA-based platforms, to support ultrasound and(or) RF system design, transducer interaction understanding, and design troubleshooting.
• Experience with circuit modeling tools such as LTSpice or equivalent.
• Experience with designs containing FPGAs.
• In-depth knowledge of electrical and ultrasound-system design, with working knowledge of related systems, software, firmware, mechanical, manufacturing, quality and regulatory disciplines.
• Ability to independently lead assigned engineering projects or major technical workstreams, coordinate contributors and maintain alignment among requirements, technical decisions, risks and deliverables.
• Ability to guide others in resolving complex or cross-functional technical issues and to identify solutions where established approaches or precedents are insufficient.
• Ability to evaluate information from multiple sources, identify conflicting evidence, exercise engineering judgment and develop technically defensible recommendations.
• Ability to facilitate complex technical discussions, articulate design trade-offs, anticipate stakeholder concerns and build consensus on decisions and actions.
• Ability to communicate complex or sensitive technical information clearly to technical and nontechnical audiences across functions and geographies.