FocusKPI, Inc.

Medical Device Risk Management Advisor (Part-Time, Remote)

FocusKPI, Inc.  •  United States (Remote)  •  3 months ago
Apply
AI can make mistakes so check important info. Chat history is never stored.

Job Description

We are building an AI-powered platform to support medical device risk management and regulatory documentation (including ISO 14971 and design controls), and are looking for a few professionals to serve as ongoing product feedback advisors.

This is a flexible, part-time opportunity for experienced professionals who can periodically test new features, review workflows, and provide practical feedback based on real-world medical device and regulatory experience. Your input will directly shape how the product supports day-to-day work in regulated environments.

What You’ll Do

  • Test new features and prototypes periodically
  • Provide feedback on usability and regulatory alignment
  • Review risk management and documentation workflows
  • Suggest improvements based on real industry practice
  • Join occasional 30–45 minute feedback sessions

Time Commitment

  • Flexible, ongoing engagement
  • Approximately 1–2 hours per week or biweekly
  • Fully remote

Preferred Background

  • Medical device regulatory affairs or quality assurance
  • Experience with ISO 14971 risk management
  • Design controls / DHF documentation
  • 510(k), De Novo, or PMA experience is a plus
  • Risk management file, FMEA, or hazard analysis experience

Consultants and industry professionals are welcome.

How to Apply

If you’re interested, please complete this short screening form so we can better understand your background:
https://forms.gle/jgj1ZN2jtAGGAbYQA

We’ll follow up with selected candidates to schedule an initial session and discuss next steps.

NOTICE: Please be aware of fraudulent emails regarding job postings, job offers and fake checks. FocusKPI's recruiting team will strictly reach out via @focuskpi.com email domain. If you have received fraudulent emails now or in the past, please report it to https://reportfraud.ftc.gov/

The domain @focuskpijobs.com is fraudulent and not related to FocusKPI. Please do not not reply or communicate to anyone with @focuskpijobs.com.

FocusKPI, Inc.

About FocusKPI, Inc.

Since our founding in 2010, we have become a premier data science and technology firm specializing in data analytics, AI, and staffing solutions. Our mission is to deliver customized solutions that drive revenue lift and cost savings through a unique structure that competes on quality, cost, and speed.

Our Core Offerings:

1. Data Analytics and Machine Learning Services

Delivering actionable business insights for high ROI results at scale. We focus on customer engagement, market adaptation, operational strategy, and performance optimization to drive growth and efficiency.

Capabilities:

Predictive Analytics

AI / Machine Learning

Measurement

Text Analysis

Key Industries Served:

Retail Media

B2B & B2C Sales, Marketing, and Merchandising

Software & Applications

2. AI-Driven Innovative Solutions

Enhancing business operating efficiency with advanced AI models and customizable interfaces. Our private deployment solutions ensure data security and control, tailored to meet unique business challenges.

Netpoint.AI - Our platform of rapid GenAI solutions prototypes.

SalesBuilder.net - Originally developed from NetPoint, is now a dedicated product specifically for sales representatives.

3. Staffing and Recruiting

Providing swift, high-quality staffing solutions to secure top tech-industry talent. We focus on high retention and rapid turnaround times, ensuring that our clients receive qualified candidates within 24 hours to meet their urgent needs.

Industry
IT & Software
Company Size
11-50 employees
Headquarters
Santa Clara, CA
Year Founded
2010
Social Media