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

Sword Health is shifting healthcare from human-first to AI-first through its AI Care platform, making world-class healthcare available anytime, anywhere, while significantly reducing costs for payers, self-insured employers, national health systems, and other healthcare organizations. Sword began by reinventing pain care with AI at its core, and has since expanded into women’s health, movement health, and more recently mental health. Since 2020, more than 700,000 members across three continents have completed 10 million AI sessions, helping Sword's 1,000+ enterprise clients avoid over $1 billion in unnecessary healthcare costs. Backed by 42 clinical studies and over 44 patents, Sword Health has raised more than $500 million from leading investors, including Khosla Ventures, General Catalyst, Transformation Capital, and Founders Fund. Learn more at www.swordhealth.com.

The Program Management Team serves as the central coordination hub across Product Development, Manufacturing Operations, Supply Chain, and external QARA partners. The team ensures regulatory compliance, manages strategic contract manufacturer relationships, and drives cross-functional programs that bring devices from concept to market and through their complete product lifecycle. It operates at the intersection of regulatory excellence, technical leadership, program execution, and operational efficiency through digital transformation.

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.

Total compensation range

€60,200 - €94,600 a year

*This range includes base, variable and equity

These compensation bands are just the starting point. Once someone joins and proves they’re outlier talent, we adjust quickly to ensure their compensation aligns with their impact.

Our job titles may span more than one career level. Actual pay is determined by skills, qualifications, experience, location, market demand, and other factors. Compensation details listed in this posting reflect the base salary and any potential variable, bonus or sales incentives, and the Company’s estimation of the value of private company stock options, if applicable. The pay range is subject to change, future value of company stock options is not guaranteed, and compensation may be modified in the future. In addition to our total compensation, Sword offers a number of benefits as listed below.