Sr Project Analyst I (Medtech)

TL;DR

Sr Project Analyst I (Medtech): Scheduling and managing activities for development projects with an accent on Design History File (DHF) and regulatory documentation. Focus on coordinating cross-functional reviews, tracking project deliverables, and maintaining project records in Confluence and JIRA.

Location: Fully remote within the United States or hybrid in Del Mar / San Diego, CA

Salary: $28.22 – $35.27 per hour

Company

A leader in the diabetes technology industry, manufacturing advanced insulin delivery systems like the Tandem Mobi and t:slim X2.

What you will do

• Plan and schedule the completion of documentation for the Design History File (DHF) and regulatory filings.
• Manage cross-functional meetings for the review and approval of product documentation.
• Maintain a comprehensive Document Tracker to record all project-related documentation.
• Track project deliverables to ensure timely completion and communicate progress to key stakeholders.
• Facilitate Design Reviews and support Project Phase Exit presentations.
• Manage and update team content on shared Confluence spaces.

Requirements

• Must be authorized to work for any employer in the U.S. (No sponsorship available).
• Location: Must be based in the United States.
• 4+ years of experience in a supporting role within an office environment.
• Experience working in the medical device industry or an ISO regulated environment.
• High proficiency in MS Office (Outlook, SharePoint, Word, Excel, PowerPoint) and MS Project.
• Proficiency with Confluence and JIRA or equivalent project management tools.
• Associates degree in a related field or equivalent job experience.

Culture & Benefits

• Flexible work arrangement with options for full remote (US) or hybrid (Del Mar, CA).
• Inclusive environment that encourages applicants to apply even if they don't meet 100% of the criteria.
• Focus on human-centered design and a personal commitment to improving lives for people with diabetes.
• Comprehensive pre-employment screening process to ensure integrity and trust.