Lead Electronics Engineer (Medical Device Development)

Position: Lead Electronics Engineer (Medical Device Product Development)

Company:

Germany)

Experience:

Location:

About InnoIQ Engineering

subsidiary of B&W Engineering und Datensysteme GmbH

(Germany)

concept through regulatory compliance and production support, we deliver innovative, highquality solutions for global clients in the medical device space.

Role Overview

As a key member of our team, you lead electronics design for new medical devices from

schematic capture and PCB layout using Altium Designer, to component selection and

prototype validation. Youll ensure full compliance with standards like IEC 60601, ISO

13485/14971, IEC 62366, and FDA 21 CFR 820.

Key Responsibilities

• End-to-End Electronics Design:

Drive schematic design and PCB layout from scratch using Altium Designer, including

creation of symbols, footprints, library management, and templates.

Perform detailed multi-layer board design with emphasis on signal integrity, EMI/EMC,

thermal performance, DRC/ERC, and DFM/DFT.

• Components & Libraries:

Build and maintain Altium library assets (schematics, PCB footprints, 3D models) and

manage lifecycle with traceability for compliance.

• Medical-Grade Standards & Design Control:

Design compliant with IEC 60601 (11 & 12), ISO 13485, ISO 14971, IEC 62366, and FDA

21 CFR 820 processes.

Support DFMEA/risk management and maintain complete Design History File (DHF).

• Prototype & Test:

Develop and execute test setups for verification/validation, including electrical safety, EMC,

and performance benchmarks.

Debug via oscilloscopes, spectrum analysers, and logic analysers through first builds and

pilot runs.

• Cross-Functional Collaboration:

Align with firmware, mechanical, QA, procurement, and manufacturing teams to ensure

seamless integration and production readiness.

Assist in NPI, including PCB prototype coordination, pilot transfers, and documentation

handoff.

• Documentation & Leadership:

Prepare engineering documents: design specs, BOMs, assembly/test procedures, test plans,

and validation reports.

Lead schematic/PCB design reviews and mentor junior engineers.

Required Skills & Experience

• Bachelors or Masters in Electronics/Electrical/Biomedical Engineering.
• 5-10 years in electronics design, ideally in medical-device or similarly regulated

sectors.

• Proficiency in Altium Designer (schematic capture, multi-layer PCB layout, library

and template creation).

• Solid knowledge of analogy/digital circuit design, power distribution, sensor/MCU

interfaces, high-speed considerations.

• Hands-on testing experience with oscilloscopes, logic analysers, EMC analysers.
• Understanding of medical standards: IEC 60601 series, ISO 13485/14971, IEC 62366,

FDA 21 CFR 820.

• Excellent documentation skills, attention to detail, and teamwork orientation