PCB Design for Medical Iontophoresis Device

I need an electronics engineer to design a PCB for a therapeutic iontophoresis medical device. The design must be suitable for IEC 60601-1 certification. Technical Requirements: The device specifications: Constant current source: 1.5 mA maximum Power: 2x 9V alkaline batteries Load range: 0-20k ohms (skin impedance) Current profile: 20 second ramp-up, 5 minute constant current, 5 second ramp-down Fail-safe circuit with fault detection LED indicators (current flow, low battery) Audible alarm for faults Microcontroller-based control Deliverables: Complete schematic (Altium, KiCAD, or Eagle) PCB layout (4-layer preferred) with proper medical device spacing Bill of Materials with component part numbers Design calculations and notes Gerber files ready for manufacturing Basic documentation explaining the design choices Required Experience: Previous PCB design for medical devices or similar regulated products Understanding of IEC 60601-1 safety requirements (creepage, clearance, isolation) Experience with precision current source circuits Analog circuit design skills Knowledge of EMC design practices Preferred Skills: Familiarity with medical device standards Experience with battery-powered precision circuits Previous work on patient-contact devices Understanding of FMEA principles Project Details: Application Requirements: Please include in your proposal: Links to 1-2 previous PCB projects (medical or precision analog preferred) Your approach to solving the voltage requirement challenge (1.5mA at 20k ohms requires 30V but supply is only 18V) Which PCB design software you use Your estimated timeline Brief explanation of your understanding of medical device PCB requirements Important Notes: The design must allow for future certification, so proper safety margins and component selection are critical I will need you to be available for weekly check-in calls Clear documentation is essential Component selection should prioritize availability and medical-grade where necessary Screening Questions: Have you designed PCBs for regulated medical or industrial equipment before? What is your experience with constant current source circuits? Are you familiar with creepage and clearance requirements for medical devices? Which PCB design tool do you primarily use? Can you commit to a 4-6 week timeline with weekly updates?