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. **Key Responsibilities** - **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. **Preferred Qualifications** - **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