Senior Electrical Engineer, Advanced Development

Merz North America•Raleigh, NC

About The Position

The Senior Electrical Engineer is part of Merz Aesthetics’ R&D Advanced Development group and is responsible for electrical hardware design, with an emphasis on ultrasonic applications, and analysis of current and new systems. The role applies electrical engineering principles to medical device design and independently leads defined engineering workstreams, coordinating internal hardware teams and external design partners to meet schedules, milestones, technical requirements, quality objectives, and cost targets. The engineer leads electrical design and integration from concept and feasibility through design verification and transfer readiness. The position requires expertise in analog and RF circuits, ultrasonic medical systems, system integration, and applicable medical-device safety and regulatory standards. It also provides technical direction, reviews engineering work and documentation, advises cross-functional teams, and mentors less-experienced engineers. The role develops and tests innovative concepts, translates clinical, user, safety, regulatory, and business needs into actionable engineering plans, and leads verification planning and complex test-method development. It assesses design trade-offs across performance, reliability, manufacturability, serviceability, cost, and lifecycle objectives.

Requirements

Bachelor of Engineering (B.E.) in Electrical Engineering, Systems Engineering, or a related field.
At least 5 years of engineering experience in ultrasound system design, ultrasound-based medical-device development, or another highly regulated engineering environment, with demonstrated ultrasound system experience.
At least 2 years of proven analog-design experience completing board-level and product designs with analog circuits.
Specific experience with board-level power supplies, power amplifiers, high-power frequency-generation synthesizers, filters, and wave shaping.
1–2 years of full development-lifecycle experience, from concept to commercialization, with at least one medical device.
1–2 years of experience with medical devices integrating 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, and ISO 14971.
Ability to understand system, subassembly, and board-level requirements and specifications methodically and in an organized manner.
Good understanding of high-speed PCB layout considerations, including parasitics, crosstalk isolation, power-supply noise, grounding, and EMI.
Familiarity with common electrical and mechanical manufacturing methods 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 such as HyperLynx or similar.
Experience with analog board-level design for frequency generation, power amplifiers, harmonic-filter suppression, wave shaping, and mixed-signal technologies.
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 engineering projects or major technical workstreams, coordinate contributors, and maintain alignment among requirements, technical decisions, risks, and deliverables.
Ability to guide others through complex or cross-functional technical issues and identify solutions where established approaches 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, explain design trade-offs, anticipate stakeholder concerns, and build consensus.
Ability to clearly communicate complex or sensitive technical information to technical and nontechnical audiences across functions and geographies.

Nice To Haves

Master’s degree in engineering, with experience in the medical-device industry and/or highly regulated engineering environments.
Experience collaborating with design partners or contract engineering firms to design and develop a medical device.
Experience overseeing contract test agencies, including resolving problems, for standardized testing.
Exposure to software-development practices and IEC 62304.
Familiarity with acoustic modeling and simulation tools such as COMSOL or other FEA-based platforms for ultrasound and/or RF system design, transducer interaction, and design troubleshooting.
Experience with designs containing FPGAs.

Responsibilities

Design, develop, and support advanced-development prototypes, subassemblies, and board-level circuits, especially analog and RF circuits, amplifiers, power supplies, converters, and microprocessor-based systems.
Lead electrical design and integration for assigned products, subsystems, or major technical workstreams from concept and feasibility through design verification and transfer readiness.
Establish technical approaches, coordinate engineering activities, identify dependencies, and ensure electrical designs satisfy system-level requirements.
Prepare engineering analyses, feasibility reports, and studies for advanced-development projects.
Provide engineering tools, equipment, and parts for cross-functional efforts and provide electrical engineering expertise throughout product lifecycles.
Advise cross-functional project teams and guide resolution of complex electrical, system-integration, and product-performance issues.
Support compliance with medical-device safety requirements, including IEC 60601 and other applicable standards.
Translate system, user, safety, regulatory, and business requirements into electrical design requirements, architecture decisions, interface definitions, and verification strategies.
Assess the effects of design decisions on performance, reliability, manufacturability, serviceability, cost, and lifecycle objectives.
Review electrical designs, analyses, and technical documentation from internal engineers and external design partners; provide direction, identify gaps, and ensure recommendations are supported by engineering evidence.
Develop, design, build, and test innovative concepts and solutions aligned with clinic, patient, and business needs.
Apply engineering best practices, emerging technologies, market and competitive information, clinical needs, and lessons from existing products to identify product and process improvements.
Guide cross-functional teams in translating ambiguous needs into testable engineering concepts and development plans.
Present technical options, trade-offs, and recommendations to stakeholders and build agreement on preferred approaches.
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 cross-disciplinary input to determine root causes and recommend corrective actions.
Develop, review, and approve test plans, procedures, methods, and data-analysis approaches tied to technical requirements and specifications.
Validate test tools or setups when required and guide development and troubleshooting of novel test methods.
Evaluate and select test methods based on technical risk, accuracy, repeatability, efficiency, and regulatory expectations.