Lead Electronics Engineer
1 day ago
Position: Lead Electronics Engineer (Medical Device Product Development)
Company: InnoIQ Engineering (Subsidiary of B&W Engineering und Datensysteme GmbH,
Germany)
Experience: 5-10 years
Location: Magarpatta, Pune
About InnoIQ Engineering
InnoIQ Engineering, a subsidiary of B&W Engineering und Datensysteme GmbH
(Germany), excels in research, design, and development of precision medical devices. From
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 & 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
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