Expert Technical Program Manager, AI Medical Hardware Products

Overview

Job Description

Responsibilities

• - Own cross-functional New Product Introduction (NPI) programs from early concept through design transfer, regulatory clearance and commercial launch.
• - Lead cross-functional execution across Hardware Engineering, Process Development, Continuous Improvement and Design Transfer, Supply Chain, and QARA partners while identifying opportunities to streamline workflows and reduce time-to-market.
• - Drive contract manufacturer selection and onboarding programs, managing technical qualification timelines, stakeholder alignment, and go/no-go decision processes across multiple functional teams with focus on efficient qualification pathways and scalable processes.
• - Help regulatory submission programs working closely with QARA, tracking milestones, managing dependencies, and ensuring technical readiness for FDA, EU, MDSAP compliant technical files.
• - Establish and manage governance frameworks for product development programs, including design reviews, technical gates, readiness assessments and risk management throughout the product lifecycle, leveraging AI/ML tools for risk prediction, schedule optimization, and automated reporting.
• - Define standardized, efficient protocols for contract manufacturer interactions on regulatory and quality matters, creating scalable digital processes and automation across all manufacturing partners.
• - Track and report on program health across the product portfolio, managing design control milestones, and NPI project schedules using advanced program management tools, automation, and AI-powered insights for proactive risk management.
• - Facilitate technical decision-making across organizational boundaries, bringing together Engineering Teams, NPI, Supply Chain, and external partners to resolve complex program challenges through efficient collaboration platforms and digital workflows.
• - Identify and implement AI/automation solutions to eliminate manual tasks, improve data quality, and accelerate program execution (e.g., automated compliance checking, AI-powered document generation, predictive scheduling).

Required Skills

• - Bachelor''s or Master''s degree in Biomedical, Mechanical, Electrical Engineering or related field.
• - 5+ years of program management or technical leadership experience in medical device industry with demonstrated track record of driving efficiency improvements.
• - 5+ years leading cross-functional NPI programs or technical projects with proven success bringing products to market on accelerated timelines.
• - Product Life Cycle Management experience with focus on process optimization and cycle time reduction.
• - Strong understanding of medical device regulatory requirements (FDA 21 CFR 820, ISO 13485, IEC 60601, EU MDR, MDSAP) with hands-on experience in design controls and quality systems.
• - Proven track record leading contract manufacturer qualification and onboarding programs from selection through commercial readiness using efficient, standardized approaches.
• - Experience coordinating complex programs with multiple stakeholders across engineering, operations, quality, regulatory, and supply chain functions.
• - Demonstrated ability to manage program schedules, identify critical path dependencies, and drive execution across organizational boundaries while continuously improving workflows.
• - Experience working in matrix organizations with external partners.
• - Strong written and verbal communication skills for technical documentation, program updates, and executive reporting.
• - Strategic thinking with ability to balance compliance requirements, technical feasibility, schedule constraints, and business objectives while identifying efficiency opportunities.
• - Proficiency with program management tools and methodologies including new digital tools and AI-powered solutions.
• - Data-driven mindset with ability to leverage metrics, analytics, and automation to improve program execution.
• - Experience with AI-powered project management or collaboration platforms.
• - Comfort operating in fast-moving, ambiguous environments while maintaining regulatory rigor.

Benefits

• - Health, dental and vision insurance
• - Meal allowance
• - Equity shares
• - Remote work allowance
• - Flexible working hours
• - Work from home
• - Discretionary vacation
• - Snacks and beverages
• - English class