Molbio Diagnostics
Website:
molbiodiagnostics.com
Job details:
Role Overview
The Manager – Engineering Services, a self-starter, owns the performance, reliability, and continuous improvement of the Engineering services for our point-of-care molecular diagnostics platforms and consumable test kits. This is an end-to-end accountability role spanning the full service lifecycle — installation, preventive maintenance, calibration, troubleshooting, complaint handling, and the field-to-R&D feedback loop.
The Manager combines strategic ownership of the service function with the hands-on institutionalization of operational rigor across hardware, firmware, and assay troubleshooting — designing, standardizing, and scaling Technical Services processes so that they grow with the installed base, while ensuring adherence to global medical-device standards (ISO 13485, MDSAP) and turning real-world field performance data into measurable product and service enhancements.
Scope & Overarching Responsibilities
- Own overall Engineering service performance across the installed base — instrument uptime, resolution time, first-time-fix, service quality, and cost-to-serve.
- Define and scale the Technical Services operating model — the processes, tooling, SLAs, and team structure required to support a growing platform footprint across regions and accounts.
- Serve as the senior escalation point and decision-maker for critical field and customer issues.
- Act as the structured bridge between the field and R&D / Systems Engineering / Quality — converting field inputs and failure trends into design, reliability, and serviceability improvements.
- Lead, develop, and grow a multi-tier field service team.
- Safeguard the regulatory and quality compliance of all service activities, records, and communications.
Key Responsibilities
1. Process Architecture & Workflow Standardisation
- Design, implement, and maintain SOPs, work instructions, and escalation matrices for field installation, preventive maintenance, calibration, and break-fix operations.
- Map and optimise service ticketing and case workflows within CRM/ERP systems to reduce Mean Time to Resolution (MTTR) and improve First-Time-Fix Rates (FTFR).
- Establish and govern Service Level Agreements (SLAs) for technical escalations, spare-parts replenishment, and depot repairs.
2. Regulatory Compliance & Quality Integration
- Oversee complaint-handling workflows in strict alignment with ISO 13485, ISO 14971, and regional post-market surveillance (PMS) mandates.
- Facilitate root-cause analysis (5-Why, Fishbone, DMAIC) and initiate/manage Corrective and Preventive Actions (CAPA) driven by field-service trends.
- Ensure calibration standards, field safety notices, and maintenance logs maintain audit-ready Service reports, PM reports traceability.
3. Data-Driven Service Operations & Analytics
- Build and track operational dashboards for technical-service KPIs — instrument downtime, failure modes by lot/batch, field-engineer utilization, and warranty costs.
- Partner with Instrumentation and R&D by synthesizing field inputs, failure-rate data, and user-error trends to guide Design for Serviceability (DFS) and Design for Reliability (DFR).
4. Technical Leadership, Training & Knowledge Management
- Lead, mentor, and upskill a team of Technical Support Specialists and Field Application / Service Engineers.
- Create structured onboarding, level-based certifications, and continuous-training curricula covering PCR instrumentation, microfluidics, electromechanical subsystems, and software integrations.
- Oversee the authoring and maintenance of technical service bulletins, Service Manuals, knowledge-base articles, and interactive troubleshooting guides.
5. Customer & Stakeholder Management
- Manage critical laboratory escalations directly with clinical laboratory directors, hospital administrators, and reference labs, protecting service commitments and customer confidence.
- Own SLA governance and voice-of-customer capture, feeding recurring field pain-points back into process and product improvement.
Key Performance Indicators (Success Measures)
MTTR • First-Time-Fix Rate • instrument uptime / downtime • SLA adherence • CAPA closure timeliness • complaint turnaround time • field-engineer utilization • warranty & service cost-to-serve • team training / certification completion.
Required Qualifications & Experience
- Education: Bachelor's degree in Biomedical Engineering, Electrical Engineering, (Master's preferred).
- Experience: 6+ years in technical service, field-service engineering, or technical operations or Process Management within the medical-device or IVD industry, including at least 2–3 years in a team-leadership or process-management capacity.
- Domain knowledge: Direct hands-on experience with IVD instrumentation, PCR / molecular diagnostic equipment, or point-of-care platforms.
- Process & quality expertise: Solid grounding in ISO 13485, FDA QSR / 21 CFR Part 820, and risk management (ISO 14971).
Desirable / Preferred
- Experience standing up or scaling a service function across a distributed installed base.
- Exposure to post-market surveillance and audit readiness in regulated markets.
Core Competencies & Skills
- Process orientation — diagnoses operational bottlenecks, develops scalable frameworks, and enforces procedural discipline.
- Analytical problem-solving — structured root-cause analysis (8D, Ishikawa, FMEA) and data tools (Power BI, Tableau, Advanced Excel).
- Cross-functional influence — interfaces smoothly with R&D, Manufacturing, Quality Assurance, Regulatory Affairs, and Commercial Sales.
- Customer focus — strong communication to manage critical lab escalations with laboratory directors, hospital administrators, and reference labs.
- People leadership — builds, certifies, and retains a high-performing technical services team.
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