Description

TACHMED is an early-stage medical device company developing connected in vitro diagnostic systems comprising biochemical assays, hardware instrumentation, and regulated software and algorithms. The company conducts in-house R&D and validation activities, with outsourced commercial manufacturing. We are seeking an experienced Electronics Engineer with experience in Verification and Validation (V&V) to take technical ownership of electronic design and development of our innovative In Vitro Diagnostic (IVD) medical device.  The device integrates advanced biosensor technology, electronics and a range of electrochemical measurement techniques for highly sensitive and selective analyte detection.

The Electronics Engineer will play a critical part in the design, development and commercialisation of the device working through from proof of concept to launch.

Requirements

Role responsibilities:

Electronic Design & Development

• Design the electronic systems that interface with biosensors and enable precise execution of advanced electrochemical measurement techniques such as: 
  • Electrochemical Impedance Spectroscopy (EIS)
  • Chronoamperometry (CA)
  • Square Wave Voltammetry (SWV)
  • Differential Pulse Voltammetry (DPV)
  • Cyclic Voltammetry (CV)
  • Dirac Point Measurement
• Develop and implement firmware or embedded algorithms for electrochemical methods
• Design analog and digital circuits for low-noise signal acquisition and processing of biosensor outputs
• Interface biosensor platforms with microcontrollers (e.g. STM32) and ensure real-time signal fidelity
• Lead PCB design, prototyping and testing in accordance with IEC 60601 and IEC 61326.
• Drive system integration of electronics with fluidics, firmware and user interface elements.

System Integration

• Collaborate closely with cross-functional teams including assay, software, mechanical, clinical, quality and regulatory to deliver a compliant, high-performance medical device
• Support integration of electronics within the wider digital ecosystem (reader, adapter, biosensor, app, and cloud)

Verification, Validation & Compliance

• Lead Verification & Validation (V&V) activities, including the development and execution of test protocols, traceability matrices and technical documentation, e.g. Design History File (DHF).
• Conduct risk management activities per ISO 14971 and ensure quality system alignment with ISO 13485.
• Support regulatory submissions (FDA, IVDR, MDR) through preparation of required documentation and technical justifications. 
• Perform troubleshooting, root cause analysis and corrective actions (CAPA) during development and design transfer
• Plan and execute electronic verification and validation activities
• Support EMC, electrical safety, and environmental testing (e.g. IEC 60601, IEC 61010 as applicable)
• Contribute to design controls, risk management, and technical documentation in line with ISO 13485 and ISO 14971
• Support regulatory submissions through provision of technical evidence and test reports
• Stay informed on evolving regulatory requirements, standards, and industry best practices related to IVD medical devices.

Manufacturing & Supply Chain Alignment

• Work closely with supply chain and manufacturing partners to ensure designs are manufacturable and scalable
• Support prototype builds, pilot production, and transition to volume manufacturing
• Resolve production issues, component obsolescence, and supplier-related risks.

Continuous Improvement & Technical Leadership

• Drive best practices in electronic design, testing, and documentation
• Identify technical risks early and propose pragmatic mitigation strategies

Key Competencies

• Proven experience as a Lead Electronics Engineer developing complex electronic products
• Experience delivering products in regulated environments, ideally medical devices or diagnostics
• Strong analogue and digital circuit design experience
• Strong knowledge of analog front-end design for sensor signal processing, including low-noise design
• Experience with electrochemical measurement techniques and instrumentation design
• Experience working closely with embedded firmware teams
• Hands-on experience supporting products from concept through to manufacture
• Experience in design controls, risk management, FMEA and medical device lifecycle processes
• Proven experience in design & development change control, verification, validation planning, execution, and documentation for FDA submission
• Ability to manage multiple priorities and work collaboratively across functions.

Skills

• Familiarity with STM32, ARM Cortex MCUs or similar embedded platforms.
• Proficiency in PCB design tools (e.g. Altium Designer, KiCAD) and simulation software (e.g. LTspice and PSpice).
• Strong knowledge of ISO 13485 (QMS), ISO 14971 (Risk Management), and IEC 60601 (Electrical Safety).
• Experience with IVD regulatory frameworks (IVDR, FDA 21 CFR Part 820, CE marking)
• Embedded interfaces (I2C, SPI, UART, USB, BLE, etc.)
• Proactive attitude and ability to self-manage
• Attention to detail
• Strong problem solving skills
• Good communication skills (verbal and written)
• Excellent organisational skills
• Knowledge of Microsoft 365.

Qualifications

• 5+ years of experience in electronics development for medical or analytical devices (IVD preferred)
• Bachelor’s or Master’s degree in Biomedical Engineering, Electronics Engineering, or a related field.