Part-Time MedTech Project Manager: FDA-Ready Delivery

Sanmai; Tucson (AZ); Hybrid; USD 140,000 - 150,000; Full time

Job summary

Sanmai is seeking a part-time Project Manager to translate strategy into execution for a medical-device startup. You will own delivery of product development projects, keep milestones on track, and ensure FDA-ready documentation across hardware, software, clinical, and regulatory domains.

The role requires hands-on, proactive leadership in a lean, fast-moving environment with hybrid work in Tucson, AZ. Expect interaction with QA and regulatory teams to maintain compliance and high-quality

Qualifications

• 5+ years of project management experience in medical device or regulated product development.
• Track record driving cross-functional projects through hardware/software integration, V&V, and FDA submissions.
• Familiarity with FDA design controls, ISO 13485, and IEC 60601.
• Strong PM toolkit (Agile, Jira, Gantt, risk tracking) and excellent communication.
• Hands-on, proactive, detail-oriented, and comfortable operating with autonomy.

Responsibilities

• Lead cross-functional execution across hardware, software, clinical, and regulatory teams.
• Translate strategy into actionable project plans in Jira/Agile; track progress, risks, and dependencies.
• Drive hardware/software integration plans, V&V plans, and documentation with our engineering and quality teams.
• Ensure deliverables meet FDA design control expectations (ISO 13485, IEC 60601, risk management, DHF).
• Keep project documentation audit- and submission-ready, partnering closely with Quality.
• Report status, risks, and priorities to leadership with clarity.

Skills

Project management

Cross-functional collaboration

Agile

Jira

Gantt

Risk tracking

Communication

Autonomy

Medical device development

Tools

Jira

Gantt charts

Job description

Sanmai is seeking a part-time Project Manager to translate strategy into execution for a medical-device startup. You will own delivery of product development projects, keep milestones on track, and ensure FDA-ready documentation across hardware, software, clinical, and regulatory domains.

The role requires hands-on, proactive leadership in a lean, fast-moving environment with hybrid work in Tucson, AZ. Expect interaction with QA and regulatory teams to maintain compliance and high-quality