Program Manager - Medical Devices

Job Description

Job Role: Program Manager (8–12 Years Experience)

Position Summary

We are seeking an experienced Program Manager to lead system-level documentation, architecture, and compliance activities for medical device projects. The role focuses on program high-quality while meeting business goals, Leading DHF remediation, and collaborating with cybersecurity, SAP, and software development teams to ensure successful and compliant project execution.

• Program Execution: Drive new product development (NPD) programs, managing the end-to-end process from design to manufacturing and launch.
• Cross-Functional Leadership: Lead cross-functional teams comprising Engineering, Regulatory Affairs, Quality, Clinical, Marketing, and Operations.
• Lifecycle Management: Ensure design controls are applied throughout the lifecycle, maintaining the Design History File (DHF) and ensuring compliance with QMS.
• Risk & Issue Management: Actively identify roadblocks, assess risks, and develop mitigation strategies, ensuring project stability.
• Phase Gate Management: Lead the team to prepare for Phase Gate reviews, facilitating Go/No-Go decisions by executive leadership.
• Budget & Schedule Management: Develop comprehensive project plans, schedules, and budgets, tracking deliverables using [MS Project or similar software].
• Stakeholder Communication: Provide regular updates to executive leadership regarding program status, risks, and budgetary impacts.
• Supplier Management: Coordinate prototype development and manage external suppliers/vendors, conducting Design for Manufacturability (DFM) reviews.

• Education: Bachelor's degree in Engineering (Mechanical, Biomedical, Electrical), Life Sciences, or a related field.
• Experience: 7+ years of experience in project/program management, with at least 3-5 years within the medical device industry.
• Regulatory Knowledge: Deep understanding of FDA 21 CFR Part 820 (QSR), ISO 13485, and EU MDR.
• Technical Familiarity: Experience in product development lifecycles, preferably with software, hardware, or mechatronics.
• Certifications: PMP (Project Management Professional) or similar certification preferred.
• Software Skills: Proficiency with PM tools (e.g., MS Project, SmartSheet) and PLM systems