Expert Technical Program Manager managing cross-functional NPI programs for AI medical hardware products. Leading compliance and technical coordination at Sword Health for innovative healthcare solutions.
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).
Requirements
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
Job title
Expert Technical Program Manager, AI Medical Hardware Products
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