Electrical Engineer II

Senseonics, Incorporated

Germantown (MD)

On-site

USD 85,000 - 125,000

Full time

3 days ago
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Job summary

Senseonics, Incorporated in Germantown, MD seeks an Electrical Engineer II to design and develop electrical and electronic systems for next-generation implantable CGM. You will own circuit design and verification within a regulated medical device environment, collaborating with firmware, mechanical, systems, and quality engineers.

The role emphasizes hands-on schematic capture, PCB layout, component selection, and design transfers through the full product lifecycle, from concept to validation

Qualifications

  • Bachelor's degree in Electrical Engineering.
  • 2–5 years of relevant electrical/electronic design experience in regulated industries.
  • Strong analog and digital circuit design fundamentals.
  • Experience with schematic capture and PCB design tools.
  • Hands-on lab equipment testing and debugging experience.
  • Excellent written and verbal communication skills.
  • Ability to plan and deliver deliverables on schedule.

Responsibilities

  • Design, simulate, and prototype analog and digital circuits for implantable and external devices.
  • Develop schematics, PCB layouts, and BOMs with mechanical engineers and vendors.
  • Select components based on performance, cost, and regulatory requirements.
  • Build and test prototypes; perform bench debugging and characterization.
  • Support verification and validation activities and document results.
  • Contribute to risk management activities (e.g., FMEA).
  • Ensure designs meet IEC 60601-1, IEC 60601-1-2, ISO 14971 and support regulatory submissions.
  • Collaborate with firmware, mechanical, systems, QA, regulatory teams.
  • Participate in design reviews and maintain documentation per DHF and design controls.
  • Support manufacturing during transfer and ramp-up.
  • Investigate and resolve field/manufacturing issues related to electrical performance.

Skills

Analog and digital circuit design
V&V and design controls
Documentation and traceability
Cross-functional collaboration
Problem solving

Education

Bachelor's degree in Electrical Engineering

Tools

Altium Designer
OrCAD
Eagle

Job description

We are seeking an Electrical Engineer II to join our Research & Development team, designing and developing electrical and electronic systems for next-generation implantable Continuous Glucose Monitor (CGM). This role is ideal for an engineer with a strong technical foundation who is ready to take on increasing ownership of circuit design, design testing, design verification through design controls within a regulated medical device environment. You will collaborate closely with mechanical, firmware, systems, and quality engineers throughout the product development lifecycle - from concept through verification and design transfer.

Key Responsibilities
  • Design, simulate, and prototype analog and digital circuits (e.g., signal conditioning, power management, sensor interfaces or battery/charging systems) for implantable and non-implantable medical devices.
  • Develop schematics, PCB layouts, and bill of materials (BOM) in collaboration with mechanical engineers and vendors.
  • Select components based on performance, reliability, cost, availability, and regulatory requirements (e.g., biocompatibility, EMC/EMI, electrical safety)
  • Build and test prototypes; perform bench-level debugging, characterization, and root-cause analysis
  • Support design verification and validation (V&V) activities, including writing test protocols, executing tests, and documenting results
  • Contribute to risk management activities (e.g., FMEA) related to electrical subsystems
  • Ensure designs comply with applicable standards (e.g., IEC 60601-1, IEC 60601-1-2, ISO 14971) and support regulatory submissions with technical documentation
  • Collaborate with cross-functional teams (firmware, mechanical, systems, quality, regulatory) to integrate electrical subsystems into complete device designs
  • Participate in design reviews and maintain thorough documentation per design control procedures (DHF, design inputs/outputs, traceability)
  • Support manufacturing and test engineering teams during design transfer and production ramp-up
  • Investigate and resolve field or manufacturing issues related to electrical performance
Required Qualifications
  • Bachelor's degree in Electrical Engineering
  • 2-5 years of relevant experience in electrical/electronic design, preferably in medical devices or another regulated industry (automotive, aerospace, industrial controls)
  • Strong deep understanding of analog and digital circuit design fundamentals
  • Experience with schematic capture and PCB design tools (e.g., Altium Designer, OrCAD, Eagle or similar)
  • Familiarity and hands on experience with lab equipment for testing and debugging (oscilloscopes, multimeters, power supplies, function generators, logic analyzers)
  • Strong problem-solving skills and attention to detail
  • Excellent written and verbal communication skills; ability to document work clearly for design history files
  • Ability to plan, execute and complete deliverables effectively and efficiently for the scope of work owned.
Preferred Qualifications
  • Experience with battery-powered or wireless medical devices
  • Familiarity with embedded systems and firmware/hardware interaction
  • Experience with wireless communication protocols (Bluetooth Low Energy, Wi-Fi, NFC)
  • Working knowledge of design control processes and experience operating within a regulated environment (FDA QSR / ISO 13485)
  • Understanding of relevant standards such as IEC 60601-1 (medical electrical equipment safety) and EMC requirements
  • Knowledge of DFM/DFT principles and experience supporting manufacturing transfer
  • Exposure to sensor technologies (biopotential, optical, pressure, temperature)
  • Experience with statistical tools for test data analysis (Minitab, JMP)
  • Prior experience supporting FDA submissions (510(k), PMA) or CE marking (MDR)
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