Project Manager

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

Project Manager / Senior Project Manager

Location: Continental US, Eastern and Central time zones preferred

Employment Type: Full-Time, Permanent

Travel: Occasional, minimal

Position Summary

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.

Key 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.

Required Qualifications

• 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.

Preferred Qualifications

• 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.