Customer Support Engineer (Technical Track) -

Job Description Location:

225 Dyer Street, Providence, RI, 02903

Department:

Customer Experience /

Operations Employment Type:

Full-Time Reports To:

Customer Support Lead (Manager-Track)

Start Date:

Q1-Q2 2026

About Orangebiomed Inc. Orangebiomed Inc. is the U.S. subsidiary of Orange Biomed Co., Ltd. (Seoul, Korea), developing and commercializing the OBM Rapid A1c At-Home OTC monitoring system for self-testing HbA1c. We are preparing for a U.S. e-commerce launch and building a robust technical customer support backbone for device troubleshooting, warranty verification, and complaint investigation under FDA and

ISO 13485

standards. Role Overview The Customer Support Engineer (CS Engineer) will begin as a key supporting member of the U.S. Customer Support team, working closely with the Customer Support Lead during the first three months of the U.S. e-commerce launch phase. During this ramp-up period, the CS Engineer will help establish and refine daily support operations — assisting with ticket triage, Helpdesk setup, FAQ content creation, and return/warranty workflow documentation. As the customer base grows and product returns begin to occur, the role will gradually expand into technical evaluation and warranty adjudication responsibilities, performing hands-on device inspections, root cause triage, and complaint documentation in compliance with FDA and

ISO 13485

standards. Key Responsibilities Launch & Operational Support (First 3 Months) Assist CS Lead with ticket queue setup, categorization, and daily triage. Manage customer communications for non-technical inquiries (order status, delivery exceptions, etc.). Support writing macros and FAQs aligned with Help Center content. Learn warranty and refund workflows to prepare for future technical evaluations. Monitor customer feedback for usability issues and prepare reports for QA/Product. Technical Support & Device Evaluation (Post-Launch) Receive and log returned devices (RMAs) from customers via the 3PL/fulfillment partner. Conduct visual, electrical, and functional inspections of devices to identify failure modes. Document findings in the RMA/Warranty Evaluation Form, linking photos/videos and serial/Lot data. Determine if issues fall under warranty coverage or user-induced damage; prepare technical summary for CS Lead review. Support rework, calibration, or component replacement per approved SOPs. Collaborate with

HQ R D/QA

for defect categorization, root cause trends, and CAPA input. Complaint Handling & Regulatory Interface Ensure complaint data capture (event date, outcome/injury, batch/Lot, device ID, and failure description). Escalate potential MDR-reportable events to

U.S. QA / HQ RA

promptly. Support post-market surveillance, trend tracking, and device history record maintenance. Maintain full traceability between complaints, RMA evaluations, and follow-up actions. Align documentation with

FDA 21 CFR

Part 820 and

ISO 13485

requirements. Tool & System Integration Utilize Helpdesk/CRM (Zendesk, Gorgias, Intercom, or Freshdesk) linked with WooCommerce to access order, refund, and warranty data. Update device evaluation status and notes directly in Helpdesk/CRM for transparency. Use WooCommerce extensions (RMA, Warranty Management, and Return Labels) for ticket automation. Support QMS documentation using tools such as MasterControl, Greenlight Guru, or Google Workspace templates. Reporting & Continuous Improvement Maintain dashboards tracking return rate, defect category, resolution time, and repeat issues. Analyze technical trends (by LOT, production date, customer geography) and report to QA/Product. Participate in weekly cross-functional reviews (CS Lead, QA, Product, Fulfillment). Recommend product or packaging improvements that reduce technical issues or customer confusion. Support training sessions for new CS staff on device handling and troubleshooting procedures. Transition Plan The first 3 months will emphasize customer-facing operational support. Beginning in Month 4, the focus will shift toward technical evaluation, complaint documentation, and device triage as product volume increases and returns begin. Qualifications Minimum B.S. in Biomedical Engineering, Electrical Engineering, or equivalent technical discipline. 2-4 years of experience in product support, device servicing, or technical QA/QC. Hands-on experience with small electronics or IVD devices preferred. Strong attention to documentation accuracy and regulatory compliance. Proficiency in Helpdesk/CRM tools and spreadsheets (Excel/Sheets dashboards). Startup mindset: launch the first workable version quickly, then iterate. Excellent written and verbal communication skills; ability to handle sensitive health-adjacent inquiries with care. Preferred Familiarity with

FDA 21 CFR 820, ISO

13485, or

ISO 14971

(Risk Management). Experience working with WooCommerce, Shopify, or Zendesk integrations. Previous exposure to CAPA systems, complaint handling, or MDR workflows. Startup experience or comfort working in lean, fast-paced environments. Multilingual (Spanish) a plus. Success Metrics (KPIs/SLAs) FRT (First Response Time): ≤ 4 business hours (email/chat); calls answered within 60 seconds. AHT (Average Handle Time): role appropriate targets by channel. 

Resolution Time:

≤ 1 business day for order/shipping; ≤ 3 business days for warranty triage. CSAT ≥ 90%, NPS tracked monthly; Abandonment Rate ≤ 5%. 

Contact Rate:

trending down by D+30 

QA Score:

≥ 90% adherence to scripts, empathy, and compliance checks. 30/60/90-Day Success (indicative) 30 Days (Operational Support Focus) Shadow and support the CS Lead in Helpdesk ticket handling (email/chat/phone). Assist with Help Center article creation and FAQ maintenance. Participate in onboarding for QMS and complaint workflows. Help configure RMA and warranty extensions in WooCommerce. 60Days Independently manage low-complexity customer tickets under CS Lead supervision. Create Helpdesk macros for order/shipping exceptions Support coordination with 3PL on minor logistics or courier exceptions. Draft RMA/Warranty flow documents in preparation for future device evaluations. 90Days Begin handling returned device evaluations without supervision. Build early defect tracking dashboard (by LOT/category). Lead weekly technical summary reports to QA and CS Lead. Maintain turnaround targets for any RMA triage initiated during this period. Working Hours & Coverage Standard coverage: Mon-Fri, 9:00 AM-5:00 PM Eastern. Occasional off-hours for urgent field investigations or escalations. No weekend shifts unless defined by incident protocol. Compensation & Benefits Competitive salary + potential performance-based bonus. Health, dental, vision insurance; PTO per company policy. How to Apply Send your resume and a brief note: 1.Example of a technical issue you diagnosed and resolved through systematic troubleshooting; 2.A short outline of how you would evaluate a returned HbA1c device under warranty; 3.Your familiarity with Helpdesk or WooCommerce integrations for device support. EEO Statement Orangebiomed Inc. is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Page | 4