Software Project Manager

Software Project Manager

Contract

Sunnyvale, CA

We are seeking an experienced Portfolio / Project Manager with strong expertise in the Medical Technology (MedTech) domain to lead cross-functional projects ensuring compliance with regulatory standards and design control processes. The ideal candidate will possess a deep understanding of FDA and ISO regulations, design control methodologies, and medical device lifecycle management.

Key Responsibilities

• Lead and manage multiple MedTech product development projects through design control, verification / validation, and regulatory submission phases.
• Ensure adherence to 21 CFR Part 820 , ISO 13485 , IEC 62304 , and ISO 14971 standards across all project deliverables.
• Drive project planning, resource allocation, risk management, and milestone tracking to ensure on-time, compliant product delivery.
• Collaborate with cross-functional teams including Quality, Regulatory, R&D, and Manufacturing 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 mitigations to senior leadership and stakeholders.

Required Qualifications