JD-Engineering & Quality Manager – Contract Manufacturing (India)
Company: Life Scanners Healthcare Pvt. Ltd. (DigiPath AI)
Location: On-site, or frequent travel to Contract Manufacturer (CM) facility in India
Reports to: VP Operations / Head of Manufacturing
Employment Type: Full-Time
Number of Positions: 1
Role Overview
DIGIPATH AI is building the VELscopeVX fluorescence oral-screening device — a critical part of our mission to detect cancer before symptoms appear. This role is the technical and quality authority ensuring our contract manufacturer (CM) in India builds VELscopeVX units correctly, consistently, and in full regulatory compliance.
You will act as the bridge between our engineering intent and the CM's production floor — combining hands-on electronics and NPI expertise with deep quality-systems ownership. Beyond overseeing the CM, you will build and lead an internal quality/engineering department that owns QMS execution end-to-end. This is a floor-first role: we need someone who inspects calibration records and process capability data in person, not someone who reviews paperwork from a desk.
Key Responsibilities
1. Contract Manufacturer (CM) Oversight & Engineering
- Own end-to-end technical and quality oversight of the CM building VELscopeVX units, ensuring build correctness and consistency batch after batch.
- Lead New Product Introduction (NPI) activities and engineering leadership for CM-manufactured product lines.
- Provide hands-on direction on SMT/PCBA assembly, LED driver circuits, and optical sub-assembly testing and calibration.
- Own ECR/ECN/ECO change control, BOM management, component obsolescence tracking, and root-cause/failure analysis for engineering issues.
- Conduct physical CM floor audits — reviewing calibration records and process capability (Cpk) data firsthand, not just paperwork.
2. Quality Management System (QMS) & Regulatory Compliance
- Build, maintain, and continuously improve the QMS in line with ISO 13485, 21 CFR 820, and CDSCO manufacturing license requirements.
- Own document control, CAPA, internal and supplier audits, and DHF/DMR maintenance.
- Apply ISO 14971 risk management principles across product and process design; incorporate sterilization/biocompatibility considerations where relevant.
3. Team Leadership & Department Building
- Build and lead an internal quality/engineering department, including Quality Engineers, Incoming/In-Process Inspectors, Document Control, and Supplier Quality Engineer.
- Be physically present on the manufacturing floor — this is not a desk-only role.
- Mentor and develop the team's technical and quality capabilities as the department scales.
4. Cross-Functional & Executive Support
- Partner with VP Operations / Head of Manufacturing on production planning, capacity, and quality performance reporting.
- Coordinate change management and control with suppliers and drive supplier quality improvement initiatives.
- Prepare concise quality and engineering status reports for leadership decision-making.
Qualifications and Experience
- BE/B.Tech in Electronics, Instrumentation, or Biomedical Engineering.
- 7–10+ years in electronics or medical device manufacturing.
- 3–5 years in NPI (New Product Introduction) or engineering leadership managing a contract manufacturer.
- Experience with ECR/ECN/ECO change control, BOM management, component obsolescence tracking, and root-cause/failure analysis.
- Direct working knowledge of ISO 13485, 21 CFR 820, and CDSCO manufacturing license requirements (India).
- Proven track record building or auditing a QMS, including document control, CAPA, internal/supplier audits, and DHF/DMR maintenance.
- Familiarity with ISO 14971 risk management; sterilization/biocompatibility exposure is a plus.
- Experience conducting physical CM floor audits — reviewing calibration records and process capability (Cpk) data firsthand, not just paperwork review.
- Proven experience managing a team of 3–8 (quality/engineering).
- Comfortable being physically present on the manufacturing floor, with frequent travel to the CM facility.
Required Skills
1. Technical & Electronics
- Hands-on experience with SMT/PCBA assembly, LED driver circuits, and optical sub-assembly testing and calibration.
- Strong grounding in root-cause and failure analysis methodologies.
2. Quality & Regulatory
- Deep familiarity with ISO 13485, 21 CFR 820, CDSCO, and ISO 14971 risk management.
- Structured problem-solving using tools such as 8D, FMEA, SPC, and CAPA.
3. Leadership & Communication
- Ability to build and lead a quality/engineering team from the ground.
- Strong stakeholder management — comfortable interfacing with CM leadership, suppliers, and internal executives.
- Clear, confident communicator across technical and non-technical audiences.
4. Organizational & Analytical Skills
- Highly organized with meticulous attention to detail on the manufacturing floor and in documentation.
- Data-driven approach to process capability (Cpk), quality KPIs, and continuous improvement.
Nice to Have
- FDA 510(k) or CE MDR submission exposure (for exporting beyond India).
- Six Sigma / Lean Manufacturing certifications.
- Experience specifically with optical/fluorescence or LED-based medical devices.
- Prior experience managing an India-based contract manufacturer on behalf of a foreign HQ.
Pay: ₹500,000.00 - ₹800,000.00 per year
Work Location: In person
