Description

You will lead and manage multiple MedTech product development projects through design control, verification/validation, and regulatory submission phases.

Responsibilities

• Drive project planning, resource allocation, risk management, and milestone tracking to ensure on-time, compliant product delivery.
• Collaborate with Quality, Regulatory, R&D, and Manufacturing teams to align on project goals and compliance requirements.
• Maintain documentation and traceability for design history files (DHF), risk management, and validation reports.
• Facilitate business-critical meetings, reviews, and design control board sessions.
• Communicate project status, risks, and mitigation plans to senior leadership and stakeholders.

Required Skills

• 8+ years of project management experience in the MedTech or medical device industry.
• Proven experience implementing Design Controls and 21 CFR Part 820 regulations.
• Strong working knowledge of ISO 13485, IEC 62304 (Software Lifecycle), and ISO 14971 (Risk Management).
• Demonstrated ability to manage multiple priorities in a compliance-driven environment.
• Expertise in Risk Management practices.
• Familiarity with Medtech development lifecycles.

Key Skills

Education

Bachelor's or Master's degrees