Expert Technical Program Manager, AI Medical Hardware Products (Hybrid/Remote)

What you'll be doing:

• 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).

What you need to have:

• 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.

What we would love to see:

• Experience implementing AI/automation tools in program management, regulatory processes, or quality systems (e.g., automated document review, AI-powered risk assessment, digital workflow automation).
• Strong knowledge of manufacturing processes, process validation, and contract manufacturer qualification requirements.
• Track record of significant efficiency improvements or cycle time reductions in product development or manufacturing operations (quantified results preferred).
• Experience with digital transformation initiatives in regulated industries.
• Experience scaling manufacturing operations from prototypes to commercial production across multiple contract manufacturers with focus on efficiency and standardization.
• Background in both start-up and medical device company environments.
• Direct experience interfacing with FDA during inspections.
• Six Sigma or quality certification (Green Belt or higher).
• Experience with quality management system software platforms, PLM systems, and advanced analytics tools.
• International regulatory experience beyond US/EU.
• Technical background in electromechanical devices or wearable medical technology.

To ensure you feel good solving a big Human problem, we offer:

• A stimulating, fast-paced environment with lots of room for creativity;
• A bright future at a promising high-tech startup company;
• Career development and growth, with a competitive salary;
• The opportunity to work with a talented team and to add real value to an innovative solution with the potential to change the future of healthcare;
• A flexible environment where you can control your hours (remotely) with unlimited vacation;
• Access to our health and well-being program (digital therapist sessions);
• Remote or Hybrid work policy;
• To get to know more about our Tech Stack, check here.

The hiring process:

• 30-minute call with the recruiter.
• 45-minute screening call with Hiring Manager.
• Technical case study and presentation.
• 1-hour program management interview with cross-functional stakeholders (Engineering, Supply Chain, QARA).
• 1-hour leadership and cultural fit interview.