This is a fully remote position, open to applicants in Texas.

📋 Description

• Oversee medical device projects from research and development through to design and manufacturing transitions.

• Strategically plan and implement manufacturing transitions in collaboration with Operations, Quality, Supply Chain, and Regulatory teams.

• Collaborate with R&D to oversee development timelines, key milestones, and phase-gate evaluations.

• Manage company-wide initiatives across Quality, Regulatory, Commercial, Customer Success, and Finance departments.

• Create and sustain project plans, timelines, budgets, risk assessments, and progress reports.

• Liaise with external partners and suppliers, including projects based in Asia that require early-morning meetings.

• Proactively identify potential risks and dependencies and lead mitigation and escalation efforts.

• Ensure all project activities adhere to relevant regulations and standards, such as ISO 13485, FDA 21 CFR Part 820, Health Canada, and IVDR.

• Relay updates, challenges, and decisions to team members and leadership.

⛳️ Requirements

• At least 5 years of project management experience in a medical device PMO setting.

• Proven experience in facilitating manufacturing transitions and supporting R&D product development.

• Experience in managing cross-functional projects across diverse business areas.

• Familiarity with design controls, change management, and quality management systems.

• Skilled in project management tools and methodologies such as MS Project, Smartsheet, Waterfall, Agile, or hybrid approaches.

• Excellent communication, organizational, and stakeholder management abilities.

• Bachelor's degree in Engineering, Life Sciences, Business, or a related discipline.

• Willingness to participate in regular early-morning meetings for Asia-based projects.

• Capable of occasional travel.

• Preferred qualifications include IVD experience, familiarity with pharmacogenetics or molecular diagnostics, PMP or equivalent certification, experience with contract manufacturers, knowledge of regulatory submissions, and experience in small or growing companies.