Electronics Engineer

Electronics Engineer – Medical Device Manufacturing & Operations

Company: DIGIPATH AI: LifeScanners HealthCare Pvt Ltd

Location: Pune, India

Experience: 3+ Years

Employment Type: Full-Time

Role Summary

Hands-on Electronics Engineer to own end-to-end manufacturing execution of the Medical Device Make in India project from project initiation through commercial production. The role demands direct engagement with manufacturers, PCB vendors, assembly partners, quality teams, and regulatory stakeholders, with strong ownership and minimal supervision.

Key Responsibilities

1. Project Ownership & Manufacturing Execution

Own end-to-end manufacturing lifecycle: prototype builds, pilot runs, validation batches, and commercial production.

Maintain project timelines, milestones, and action trackers; visit manufacturing facilities as required.

Coordinate with manufacturers and ensure all production activities meet approved standards.

2. PCB Manufacturing, Assembly & Testing

Review and execute PCB design files, Gerber files, BOMs, schematics, and assembly drawings.

Support PCBA, functional testing, troubleshooting, and validation at vendor sites.

Maintain DHRs, technical files, test reports, and engineering change documentation (ECR/ECO).

3. Quality Assurance & Process Control

Manage QA/QC, inspection protocols, incoming material review, and production quality standards.

Conduct root cause analysis (RCA) and implement CAPA for manufacturing and quality issues.

Maintain SOPs, control plans, and work instructions per ISO 13485 requirements.

4. Vendor & Supplier Management

Coordinate with component suppliers for procurement, sourcing, and production scheduling.

Conduct vendor qualification, audits, and ongoing supplier performance monitoring.

Act as primary technical point between the company and all manufacturing/supply partners.

5. Regulatory Compliance & Documentation

Prepare documentation for CDSCO, BIS, IEC, EMC/safety testing, and other applicable regulatory requirements.

Support product certifications, audits, inspections, and ISO 13485 / ISO 14971 compliance activities.

Manage shipment readiness, packaging compliance, and logistics coordination.

Required Qualifications

B.E./B.Tech or M.E./M.Tech in Electronics Engineering, Electrical, Instrumentation, or related field.

3+ years in electronics manufacturing, NPI, product/manufacturing engineering, or medical device production.

Experience working with contract manufacturers and electronics/component vendors.

Strong documentation, communication, and project management skills; able to work independently

Required Technical Skills

PCB design file interpretation (Gerber, BOM, schematics); hands-on PCBA and SMT/through-hole experience.

Electronics troubleshooting using oscilloscopes, multimeters, and standard test instruments.

Knowledge of power electronics, embedded hardware, LEDs, sensors, cables, and connectors.

ISO 13485 QMS, CAPA, DHR/technical file management, and traceability practices.

CDSCO regulations, BIS certification, IEC, and EMC/safety testing awareness.

MS Office proficiency; PLM/ERP tools experience is an advantage.

Preferred Skills

Prior experience in medical device or regulated electronics manufacturing.

Exposure to optical/electro-optical devices, LED-based diagnostics, or portable medical devices.

Familiarity with CE Marking, FDA 21 CFR Part 820, or international medical device standards.

NPI stage-gate processes, DFM reviews, and process validation (IQ/OQ/PQ).

Lean manufacturing, Six Sigma, or SPC knowledge

Pay: ₹60,000.00 - ₹80,000.00 per month

Work Location: In person