Staritas Asia Pacific Hiring! Full Time Engineer, Clinical Data Management - Analysis in Selangor - Ricebowl

ABOUT THE ROLE

The Engineer, Clinical Data Management & Analysis, will focus on functional equivalents and device comparisons, which will play a vital role in conducting or reviewing preliminary research to define project scope and identify key product attributes that influence purchasing decisions, while ensuring our company's data accuracy and quality. In this position, you will be responsible for meticulously creating, reviewing, and organizing information into our databases and systems[JR1.1]. You'll be the bridge between various data sources and company databases, ensuring that all information is captured, formatted, and stored correctly so our clients can make informed decisions. You will contribute directly to the organization’s core data assets powering Staritas’s Global Supply Chain Solutions, ensuring high-quality, structured, and scalable intelligence.

RESPONSIBILITIES

1. Functional Equivalents (FE) Development & Maintenance

• Identify and validate clinically acceptable alternative products based on:

o Technical specifications

o Clinical use cases

o Performance characteristics

• Define and maintain functional equivalence key performance indicators (KPIs) & weights

• Support the development of FE matching logic and scoring methodologies

• Collaborate with SMEs to validate equivalence assumptions and edge cases

2. Device Comparison & Product Intelligence

• Conduct comparative analysis of medical devices, including:

o Feature/function comparison

o Performance benchmarks

o Regulatory classifications

o Clinical evidence reviews

• Develop or review structured device comparison frameworks and attribute models

• Contribute content to support the side-by-side comparison datasets for use in:[JR2.1]

o Proposal Analysis

o Value Analysis Committees

o Market intelligence products

• Identify key differentiators influencing purchasing decisions

3. Product Research & Data Modeling

• Perform deep research using:

o Internal datasets 

o External sources (e.g., FDA GUDID, clinical literature, manufacturer specs)

• Identify and define critical product attributes and taxonomies

• Contribute to product ontology/master data models

• Continuously update knowledge based on technology and regulatory changes

4. Data Management & Quality Assurance

• Accurately capture, structure, and maintain product and comparison data[JR3.1]

• Ensure >99% data accuracy and completeness

• Identify and resolve:

o Inconsistent units of measure

o Missing attributes

o Conflicting specifications

• Maintain data according to standardized classification and governance rules

• Support data readiness for publication and downstream analytics

5. AI & Automation Enablement (Forward-Looking)

• Validate and improve AI-generated product matches and attribute extraction

• Provide feedback to enhance:

o Matching algorithms

o Data standardization models

• Participate in initiatives to automate data ingestion and comparison workflows

6. Reporting & Collaboration

• Generate summaries and insights for internal and client-facing use

• Partner with:

o US-based teams

o Data Engineering / MDM teams

• Communicate findings, risks, and recommendations clearly

• Meet defined productivity and turnaround SLAs

REQUIREMENTS

• Bachelor’s Degree Required, preferably in biomedical and/or electrical engineering and/or related clinical science field. Master’s degree in biomedical and/or electrical engineering and/or related clinical science field preferred.

• 1 to 3 years' work experience in clinical science, engineering, or a related discipline.

• Ability to connect: Device attributes  Clinical relevance  Purchase decisions 

• Ability to communicate effectively and concisely both orally and in writing.

• Should have a proven track record of dependable, reliable, and thorough performance and be able to manage changing priorities for multiple simultaneous tasks.

• Proficient with Microsoft Office 365 Suite of products (e.g., Word, Excel, and PowerPoint).

• Must demonstrate independent thinking with a clear, logical line of reasoning; issues must be well thought out and clearly presented.

• Must demonstrate strong problem-solving abilities with good engineering/scientific judgment.

• Must recognize areas of concern and/or controversy and bring these to the attention of appropriate Staritas staff with recommended solutions.

• Must remain current with technological and regulatory developments within the fields of major medical experience and interest.

• Innovation and creativity are expected in developing effective, timely, and economical methods to complete one’s own assignments.

• The ability to participate in and manage multiple simultaneous activities in an effective manner is expected.