Hybrid Expert Technical Program Manager, AI Medical Hardware Products

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About the role

  • 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

Job type

Experience level

Mid levelSenior

Salary

€60,200 - €94,600 per year

Degree requirement

Bachelor's Degree

Location requirements

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