Job Description

Job Title: Early Diagnostic Kit Developer (Biomedical Engineering)

Department: R&D - Point-of-Care Diagnostics

Employment Type: Full-Time

Role Overview

We are seeking an experienced Early Diagnostic Kit Developer with a strong Biomedical Engineering background to lead the development of rapid, point-of-care diagnostic kits.

This role focuses on assay-device integration, lateral flow system design, biomarker translation into devices, and development of clinically reliable prototypes suitable for early disease detection.

It is ideal for professionals who have previous hands-on experience in developing diagnostic kits (LFA / IVD / rapid tests) and understand both biological assays and device engineering constraints.

Key Responsibilities

Design and develop lateral flow-based diagnostic kits for early disease detection.

Translate biomarker science into device-compatible assay architectures.

Optimize strip design, membrane selection, pad architecture, and fluidics.

Work on antibody-nanoparticle conjugation systems and assay chemistry optimization

Integrate plasma separation membranes for whole-blood compatibility.

Develop and evaluate prototype cassettes, strip layouts, and user interfaces

Conduct analytical performance testing (LoD, specificity, repeatability, stability).

Support scale-up feasibility, manufacturability, and design-for-production.

Prepare technical documentation, SOPs, and design validation reports.

Collaborate with clinical, regulatory, and product teams for translation readiness.

Required Qualifications

Bachelor's/Master's or Ph.D. degree in Biomedical Engineering

(or closely related disciplines such as Medical Devices Engineering, Bioinstrumentation, Clinical Engineering, or Translational Engineering)

2-7 years of direct experience in early diagnostic kit development, including

Lateral flow assays (LFA

Rapid diagnostic tests (RDTs)

Point-of-care or IVD devices

Proven hands-on experience with

LFA strip architecture and cassette design

Membrane selection (nitrocellulose, sample pads, conjugate pads)

Assay-device integration

Prototype development and troubleshooting

Strong understanding of:

Immunoassay principles (sandwich assays preferred)

Fluidics and capillary flow in paper-based devices

Signal generation and visual readout systems

Preferred Experience & Skills

Prior experience working on early detection or screening diagnostics (oncology, infectious disease, metabolic disease)

Experience integrating whole blood into point-of-care devices.

Familiarity with gold nanoparticle-based detection systems.

Understanding of analytical validation parameters (LoD, specificity, cross-reactivity).

Exposure to design controls, ISO 13485 workflows, or IVD documentation.

Ability to work in fast-paced, early-stage R&D environments with high ownership.

What We're Looking For

A hands-on diagnostic engineer, not a purely academic researcher.

Someone who understands how to convert biomarker science into a usable product.

Strong problem-solving ability in assay-device integration.

Comfortable working with ambiguity, early prototypes, and iterative development.

Why Join Us

Opportunity to work on first-in-class early diagnostic technologies.

Ownership of core diagnostic platform development.

Exposure to the full lifecycle: concept ? prototype ? validation ? scale-up.

High scientific rigor with real-world clinical impact.

Job Type: Full-time

Pay: ?70,000.00 - ?100,000.00 per month

Education:

Master's (Preferred)
Experience:

kit developement: 2 years (Required)
Work Location: In person