Technical Program Manager

Intellectt is seeking an experienced Technical Program Manager (TPM) to lead cross-functional New Product Development (NPD) programs within a fast-paced Medical Technology (MedTech) environment. The ideal candidate will have strong program leadership skills, technical knowledge of medical device development, excellent stakeholder management capabilities, and proven experience delivering complex products in regulated environments. Key Responsibilities:

• Lead end-to-end medical device New Product Development (NPD) programs from concept through commercialization.
• Develop integrated program plans, milestones, schedules, budgets, and resource plans.
• Coordinate cross-functional teams, including Systems, Hardware, Software, Firmware, Mechanical, Quality, Regulatory, Clinical, Manufacturing, and Supply Chain.
• Manage program governance, executive reporting, stakeholder communications, and decision-making processes.
• Identify, assess, and mitigate technical, regulatory, operational, and schedule-related risks.
• Facilitate design reviews and ensure compliance with medical device Design Controls.
• Support compliance with FDA regulations, ISO 13485, ISO 14971, and IEC 62304 standards.
• Drive verification, validation, design transfer, and product launch activities.
• Manage vendors, suppliers, and external development partners.
• Track critical path activities and resolve program execution challenges.
• Drive continuous improvement in program management processes and methodologies.

Project/Program Management, Technical Leadership, Project/Program Management, Medical Equipment, Technical Leadership, Product Development, Leadership, Cross-Functional, Program Planning, Budgeting, * Bachelor’s degree in Engineering, Life Sciences, or a related technical field.

• 8+ years of experience in Technical Program Management, Program Management, or Product Development leadership.
• 5+ years of experience in Medical Devices, Diagnostics, Digital Health, or regulated healthcare environments.
• Proven experience delivering complex New Product Development (NPD) programs through commercialization.
• Strong knowledge of Design Controls, Risk Management, Verification & Validation (V&V), and Design Transfer.
• Experience working in FDA-regulated and ISO 13485 environments.
• Excellent leadership, communication, stakeholder management, and problem-solving skills., * PMP certification or equivalent.
• Experience with Class II or Class III medical devices.
• Experience in hardware-software integrated product development.
• Knowledge of Agile and traditional program management methodologies.
• Experience managing global teams and external development partners.

• Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:
• Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.
• Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.
• Paid Time Off (PTO): No PTO other than that required by applicable state and local laws.