Project Manager

Genomadix • Austin, TX

17d • $90,000 - $120,000 • Remote

About The Position

Genomadix is seeking a Project Manager or Senior Project Manager to lead cross-functional projects across the organization. This role will manage R&D development programs and manufacturing transfers and will also support broader company initiatives spanning multiple functions. The level of the role will be determined based on the successful candidate's experience.

Requirements

• Minimum 5 years of project management experience within a medical device PMO environment.
• Demonstrated experience supporting manufacturing transfers and R&D product development.
• Experience managing cross-functional projects across a variety of business functions.
• Working knowledge of design controls, change control, and quality management systems.
• Proficiency with project management tools and methodologies (e.g., MS Project, Smartsheet; Waterfall, Agile, or hybrid).
• Strong communication, organizational, and stakeholder management skills.
• Bachelor's degree in Engineering, Life Sciences, Business, or a related field.
• Available for regular early-morning meetings to support Asia-based projects.
• Able to travel occasionally.

Nice To Haves

• In vitro diagnostics (IVD) experience; pharmacogenetics or molecular diagnostics a strong asset.
• PMP or equivalent project management certification.
• Experience working with contract manufacturers.
• Familiarity with FDA 510(k)/De Novo, Health Canada medical device licensing, or IVDR.
• Experience working in a small or growing company.

Responsibilities

• Lead medical device projects from R&D development through design transfer and manufacturing transfer.
• Plan and execute manufacturing transfers in coordination with Operations, Quality, Supply Chain, and Regulatory.
• Partner with R&D to manage development timelines, milestones, and phase-gate reviews.
• Manage company-wide projects across functions including Quality, Regulatory, Commercial, Customer Success, and Finance.
• Build and maintain project plans, schedules, budgets, risk registers, and status reports.
• Coordinate with external partners and suppliers, including Asia-based projects that require early-morning meetings.
• Identify risks and dependencies early, and drive mitigation and escalation.
• Ensure project work complies with applicable regulations and standards (e.g., ISO 13485, FDA 21 CFR Part 820, Health Canada, IVDR).
• Communicate progress, issues, and decisions clearly to team members and leadership.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level