Senior PM - Medical Device R&D & Manufacturing Transfers

Genomadix; Austin (TX); On-site; USD 110,000 - 170,000; Full time

Job summary

Genomadix seeks a Project Manager or Senior Project Manager to lead cross-functional projects, overseeing R&D development programs and manufacturing transfers. You will collaborate with Operations, Quality, Regulatory, and Finance to ensure milestones are met and risks are mitigated.

The role requires strong communication skills, a background in medical devices, and the ability to coordinate with Asia-based teams for early-morning meetings.

Qualifications

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

Responsibilities

• Lead medical device projects from R&D through design and manufacturing transfer.
• Plan and execute manufacturing transfers 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 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 with early-morning meetings.
• Identify risks and dependencies early, and drive mitigation and escalation.
• Ensure compliance with ISO 13485, FDA 21 CFR Part 820, Health Canada, IVDR.

Skills

Project management

Cross-functional work

MS Project

Smartsheet

Waterfall/Agile

Communication

Stakeholder management

Regulatory awareness

Education

Bachelor's degree in Engineering, Life Sciences, Business, or related field

Job description

Genomadix seeks a Project Manager or Senior Project Manager to lead cross-functional projects, overseeing R&D development programs and manufacturing transfers. You will collaborate with Operations, Quality, Regulatory, and Finance to ensure milestones are met and risks are mitigated.

The role requires strong communication skills, a background in medical devices, and the ability to coordinate with Asia-based teams for early-morning meetings.