Hardware & Product Development — P2
HARDWA.HARDWARE5E6E.P2
Designs, develops, and validates physical hardware and electronics for health technology and medical devices — spanning schematic capture, PCB layout, circuit design, embedded systems, power architecture, and EMI/EMC. Distinct from firmware/software focuses (which own embedded code and integration logic) and from regulatory/quality focuses (which own QMS and submissions); this focus owns the physical electronic design through compliance with medical electrical safety standards such as IEC 60601-1.
Designs, develops, and validates physical hardware and electronics for health technology and medical devices — spanning schematic capture, PCB layout, circuit design, embedded systems, power architecture, and EMI/EMC. Distinct from firmware/software focuses (which own embedded code and integration logic) and from regulatory/quality focuses (which own QMS and submissions); this focus owns the physical electronic design through compliance with medical electrical safety standards such as IEC 60601-1.
Focus — Hardware & Product Development
Designs, develops, and validates physical hardware and electronics for health technology and medical devices — spanning schematic capture, PCB layout, circuit design, embedded systems, power architecture, and EMI/EMC. Distinct from firmware/software focuses (which own embedded code and integration logic) and from regulatory/quality focuses (which own QMS and submissions); this focus owns the physical electronic design through compliance with medical electrical safety standards such as IEC 60601-1.
Material SKILL differential vs the function baseline.
Responsibilities by level
What this person actually does at each level on the professional track — escalating scope, not one generic blob. Your level is highlighted.
- Assists in the design and development of hardware components under senior engineer supervision, ensuring adherence to specifications and quality standards
- Contributes to schematic design, PCB layout, and prototype testing for new product designs using tools such as Altium Designer and Cadence
- Participates in prototyping, testing, and debugging of hardware systems, capturing measurements in LabVIEW and logging defects in Jira
- Contributes to technical documentation including schematics, specifications, and test reports
- Collaborates with cross-functional teams to support integration of hardware with software solutions
- Leads smaller projects or discrete components of larger hardware initiatives with general instruction and routine independence
- Optimizes hardware designs for performance and manufacturability, applying DFM and DFA principles and validating mechanical fit in SolidWorks or AutoCAD
- Owns discrete systems such as a power subsystem or a communication interface (I2C, SPI, USB) rather than individual tasks
- Interfaces with suppliers and manufacturers to resolve component selection and assembly questions
- Develops specialized expertise in a chosen area such as analog circuit design or wireless communication, running circuit simulations in SPICE and MATLAB
- Drives hardware design for diverse circuit and board-level problems with day-to-day independence, planning own work toward project milestones
- Conducts rigorous testing, validation, and debugging of analog and digital circuits, applying statistical analysis in Minitab or SAS to characterize performance
- Coordinates project activities across electrical, mechanical, and firmware contributors to integrate hardware and software
- Applies EMI/EMC mitigation techniques and regulatory standards (FCC, CE, UL) during design to support certification
- Mentors junior engineers on schematic capture, PCB layout, and prototype bring-up, tracing requirements in JAMA
- Leads cross-functional teams to drive hardware development projects from concept to production, ensuring timely delivery and adherence to specifications
- Takes a vague business problem, figures out what to build, and carries the hardware solution end to end
- Performs in-depth analysis of complex variables across power architecture, signal integrity, and miniaturization trade-offs
- Oversees integration challenges between hardware and firmware and provides technical leadership across the project
- Selects design methods and tools, and contributes to design controls and risk management documentation (DFMEA, hazard analysis) within the eQMS
- Drives hardware design strategy for new products, contributing to broader company objectives and product roadmap decisions
- Acts independently on broad or special assignments involving intangibles such as novel architectures with no established precedent
- Provides expert technical leadership on advanced circuit materials and miniaturization techniques across multiple programs
- Serves as an external spokesperson with suppliers, certification bodies, and partners on hardware capability and standards
- Builds influential cross-functional networks and may supervise others on specialized hardware initiatives
- Serves as technical authority for hardware and electrical design, driving innovation and setting technical standards across the organization
- Leads electrical system architecture for medical devices, defining power distribution, grounding strategy, isolation schemes, and safety architecture
- Ensures compliance with medical electrical safety standards including the IEC 60601-1 series across the device portfolio
- Designs high-level system architecture and makes key decisions about technical direction with full independence
- Mentors engineering teams, oversees research and development and innovation efforts, and sets department goals with clear implementation roadmaps
- Sets long-term hardware engineering direction that impacts company-wide strategy and anticipates emerging challenges in health technology electronics
- Solves ambiguous, precedent-free problems — pioneering new architectures, materials, or miniaturization approaches with broad business consequences
- Develops new methods, models, or platform technologies that advance the organization's hardware practice and influence industry standards
- Networks with executives, regulators, and industry leaders, persuading and educating senior stakeholders on strategic hardware and safety priorities
- Provides high-level mentorship to senior and principal engineers, shaping company-wide capability without requiring direct reports
Level guidelines
The universal leveling rubric applied to this function — how scope, complexity, collaboration, and experience step up across levels.
| Level | Knowledge & Application | Complexity & Problem Solving | Collaboration & Interaction | Typical Degree & Years |
|---|---|---|---|---|
| P1 | Applies foundational electrical engineering knowledge to schematic capture and PCB layout tasks using detailed instruction and standard tools such as Altium Designer, Cadence, and LabVIEW. | Solves routine hardware problems with standard answers, escalating anything outside defined specifications. | Maintains stable internal relationships, working within the immediate hardware team under close supervision. | 0–1 years; new graduate or intern with a degree in electrical, electronics, or biomedical engineering. |
| P2 | Applies conventional circuit design and DFM/DFA knowledge to discrete subsystems, exercising judgment in familiar contexts such as power or interface design and validating layouts in SolidWorks or AutoCAD. | Handles moderate-complexity problems, selecting among established design approaches with some routine independence. | Builds productive project relationships, interfacing directly with suppliers and manufacturers; may mentor junior staff. | 2+ years with a BA/BS, or an MS/PhD with no prior experience. |
| P3 | Applies broad analog and digital circuit knowledge across diverse hardware problems, evaluating identifiable factors, applying EMI/EMC and regulatory standards, and using Minitab or SAS for design characterization. | Evaluates identifiable design factors to resolve diverse circuit and board-level problems, working independently with milestone review. | Networks with senior professionals and coordinates project activities across electrical, mechanical, and firmware contributors. | 5+ years (BA), 3 years (MA), or PhD without experience. |
| P4 | Applies in-depth expertise across power architecture, signal integrity, and risk management to complex hardware issues with functional impact, managing design controls and traceability in eQMS and JAMA. | Performs in-depth analysis of complex and interacting variables, selecting methods and carrying solutions end to end. | Coordinates across groups and may lead or supervise project teams; influences technical decisions across functions. | 8+ years, often with graduate education in a relevant engineering discipline. |
| P5 | Applies expert-level mastery of advanced circuit materials, miniaturization, and hardware architecture to strategic and unique assignments. | Solves problems involving intangibles and novel architectures with high independence and no established precedent. | Builds influential networks, acts as an external spokesperson, and may supervise others on specialized assignments. | 12+ years with extensive hardware design expertise. |
| P6 | Applies field-defining mastery of medical device electrical architecture — power distribution, isolation, safety, and IEC 60601-1 compliance — to organization-wide hardware direction. | Provides visionary, field-shaping problem-solving on critical hardware and safety architecture with full independence. | Influences industry and company as a recognized thought leader, mentoring engineering teams and influencing peer professionals. | 15+ years; principal hardware expert, often with PhD plus industry leadership. |
| P7 | Develops new theories, models, and platform technologies that advance the hardware practice and influence industry standards in health technology electronics. | Solves ambiguous, precedent-free problems with broad business and industry consequences; defines long-term technical roadmaps. | Networks with executives, boards, regulators, and industry leaders; persuades and educates senior stakeholders on strategic priorities. | 20+ years, or equivalent recognition (often PhD plus significant industry contributions, patents, or publications). |
Skills
Focus-specific skills the role applies — the relevance layer beyond the occupational base.
- PCB layout and schematic capture
- Designing printed circuit board layouts and capturing circuit schematics for hardware products.
- Circuit design (analog and digital)
- Extensive knowledge of designing analog and digital circuits.
- Embedded systems and microcontrollers
- Experience with embedded systems and microcontrollers such as ARM and FPGA.
- Wireless communication technologies
- Familiarity with wireless technologies such as Bluetooth, Wi-Fi, and Zigbee.
- Communications standards and protocols
- Experience with NFC, USB, I2C, SPI, Bluetooth, and Wi-Fi interfaces.
- Design for Manufacturability (DFM) and Design for Assembly (DFA)
- Designing products to be efficiently manufactured and assembled.
- Hardware simulation and modeling
- Expertise in tools such as SPICE and MATLAB for simulating and modeling hardware.
- Regulatory compliance standards
- Understanding of standards such as FCC, CE, UL for hardware certification.
- Medical device safety standards
- Knowledge of IEC 60601 series for safety and essential performance of medical electrical equipment.
- EMI/EMC mitigation
- Designing for electromagnetic interference and compatibility in high-reliability electronics.
- Power architecture
- Defining power distribution, isolation schemes, and high-reliability power systems.
- Design controls and risk management
- Hands-on experience with design controls and full risk management lifecycle for medical products.
- DFMEA and risk documentation
- Design failure mode and effects analysis, hazard analysis, risk control verification, and residual risk justification.
- Advanced circuit materials and miniaturization
- Working knowledge of advanced circuit materials and miniaturization techniques.
- Altium Designer
- Uses this tool/technology effectively during the delivery of day-to-day tasks.
- Cadence
- Uses this tool/technology effectively during the delivery of day-to-day tasks.
- SolidWorks
- Uses this tool/technology effectively during the delivery of day-to-day tasks.
- AutoCAD
- Uses this tool/technology effectively during the delivery of day-to-day tasks.
- Minitab
- Uses this tool/technology effectively during the delivery of day-to-day tasks.
- SAS
- Uses this tool/technology effectively during the delivery of day-to-day tasks.
- National Instruments LabVIEW
- Uses this tool/technology effectively during the delivery of day-to-day tasks.
- JAMA
- Uses this tool/technology effectively during the delivery of day-to-day tasks.
- eQMS
- Uses this tool/technology effectively during the delivery of day-to-day tasks.
- Jira
- Uses this tool/technology effectively during the delivery of day-to-day tasks.
Provenance
The evidence base behind this profile — every layer is sourced; quality is scored by an adversarial review panel (1–5; passes at ≥4 on the minimum dimension).
16 sources
- O*NET 17-2061.00 (https://www.onetonline.org/link/summary/17-2061.00)
- O*NET 17-2031.00 (https://www.onetonline.org/link/summary/17-2031.00)
- BLS (https://www.bls.gov/ooh/architecture-and-engineering/biomedical-engineers.htm)
- Himalayas (https://himalayas.app/job-descriptions/hardware-engineer)
- Teal (https://www.tealhq.com/career-paths/hardware-engineer)
- FullScale (https://fullscale.io/blog/software-engineer-titles-hierarchy/)
- Medium/erwindev (https://medium.com/@erwindev/building-an-engineering-ladder...)
- DataAnnotation (https://www.dataannotation.tech/developers/staff-vs-senior-engineer)
- J&J Careers (https://www.careers.jnj.com/en/jobs/r-064006/principal-electrical-engineer/)
- University of San Diego (https://onlinedegrees.sandiego.edu/principal-engineer-vs-senior-engineer/)
- Tech Interview Handbook (https://www.techinterviewhandbook.org/engineering-levels/)
- Indeed (https://www.indeed.com/q-medical-device-control-systems-engineer-jobs.html)
- Neko Health/General Catalyst (https://jobs.generalcatalyst.com/)
- Intertek (https://www.intertek.com/medical/regulatory-requirements/iec-60601-1/)
- AAMI (https://array.aami.org/doi/full/10.2345/0899-8205-54.3.220)
- Wikipedia IEC 60601 (https://en.wikipedia.org/wiki/IEC_60601)
Level — P2 — Developing Professional
Early-career professional; developing skills, handles routine tasks with some independence
- Scope
- Defined deliverables / small features
- Autonomy
- General supervision; reviewed at milestones
- Complexity
- Some non-routine problems; applies established patterns
- Impact
- Own and immediate-team deliverables
- Decision rights
- Routine technical choices within guidance
- Leadership
- May guide interns
- Typical experience
- 1–3 yrs
Adjacent roles
Nearest roles by structural coordinates (level + taxonomy). Distance 0 → 1; each carries its 3-state match band. How coordinates work → · Compare side-by-side →
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O*NET / SOC
- code=17-2061source=jfm-factory.resolve