Project Manager

Sanmai • Full-time • Bay Area, California, United States • 6d ago

Role Overview

As Program Manager, you will be the engine that translates Sanmai’s strategy into reality. You will own execution of Sanmai’s product development programs, ensuring milestones are delivered on time, documentation is FDA-ready, and cross-functional teams remain aligned. This is a highly collaborative and hands-on role that requires strong medtech program experience, attention to detail, and the ability to thrive in a fast-paced startup environment.

What You Will Achieve

Drive product development execution, ensuring hardware completion and software integration for pivotal trials.
Ensure program documentation and processes meet FDA submission standards.
Align cross-functional teams to deliver on Sanmai’s mission.
Build scalable execution practices that strengthen Sanmai’s ability to deliver future programs.

Responsibilities

Program Execution & Alignment

Lead cross-functional execution for Sanmai’s product development, ensuring milestones are met across hardware, software, clinical, and regulatory teams.
Translate company strategy into actionable project plans in Jira/Agile frameworks (or others); track progress, risks, and dependencies.
Coordinate integration efforts across hardware, software, and clinical workflows.
Report program status, risks, and priorities to the executive team with clarity and transparency.

Product Development & Regulatory Readiness

Work closely with engineers to drive hardware design integration, software development, V&V testing, and documentation.
Ensure deliverables meet FDA design control expectations (ISO 13485, IEC 60601, risk management, DHF completeness).

Quality, Compliance & Documentation

Maintain all project documentation in audit- and submission-ready form.
Partner with Quality to ensure SOPs and processes are consistently upheld and improved.
Drive alignment between execution and compliance requirements at every stage.

Continuous Improvement

Identify bottlenecks early and implement mitigation plans.
Refine tools, workflows, and processes to strengthen Sanmai’s ability to deliver product programs at scale.
Foster a culture of accountability, ownership, and clear communication across teams.

Qualifications

Experience

5+ years of program or project management experience in medical device or regulated product development.
Proven track record driving cross-functional programs through hardware/software integration, V&V, and FDA submissions.
Familiarity with regulatory frameworks (FDA design controls, ISO 13485, IEC 60601).
Experience managing CROs, vendors, and external partners.

Skills

Strong project management capabilities (Agile, Jira, Gantt, risk tracking).
Excellent organizational and communication skills; able to keep complex programs aligned.
Competent in documentation practices for FDA-regulated products.
Budgeting and resource management skills.

Attributes