This role is responsible for managing Class III R&D projects in the medical device industry, leading them from concept development all the way to product launch. You’ll need a strong understanding of science, technology, and regulations to ensure new products meet stringent quality and safety standards.

Key Responsibilities:

• Manage all project phases: concept development, planning, execution, and launch.
• Lead and assemble project teams with diverse skillsets.
• Oversee design control activities, including defining requirements, milestones, and conducting reviews.
• Manage project scope, schedule, budget, and ensure deliverables are met on time.
• Stay up-to-date on relevant product regulations and standards (FDA).
• Facilitate communication across departments and manage project issues.
• Ensure compliance with internal procedures and quality standards.
• Lead team meetings and effectively communicate project status to stakeholders.

Qualifications:

• Bachelor’s degree in Engineering (Biomedical, Chemical, etc.).
• Minimum 4+ years of experience in medical devices or similar regulated industries.
• Proven experience in product development processes and business acumen.
• At least 2 years of project management experience.
• Excellent cross-functional coordination skills.
• Verification and Validation experience with FDA regulations.
• Experience with design of experiments, statistical analysis, and data analysis tools.
• Prior experience with interventional medical devices and ISO 13485 standards.
• Knowledge of FDA 510(k)/PMA process (preferred).

This role offers an exciting opportunity to be at the forefront of medical device innovation, leading projects that can have a significant impact on patient lives.