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Expert Technical Program Manager, AI Medical Hardware Products (Hybrid/Remote) at swordhealth
swordhealthPorto·1w ago
ManagerFull-timeAWSGitGoAIML
Salary Range
€60,200 - €94,600 /year
About the Role
Sword Health is seeking a Program Manager to lead cross-functional New Product Introduction (NPI) programs for medical devices. This role will ensure regulatory compliance and drive efficiency across product development, manufacturing, and supply chain operations.
Key Responsibilities
- →Own cross-functional NPI programs from concept through design transfer, regulatory clearance, and commercial launch
- →Lead execution across Hardware Engineering, Process Development, Supply Chain, and QARA partners
- →Drive contract manufacturer selection and onboarding programs
- →Help regulatory submission programs working closely with QARA
- →Establish governance frameworks for product development programs
- →Define standardized protocols for contract manufacturer interactions
- →Track and report on program health across the product portfolio
- →Facilitate technical decision-making across organizational boundaries
- →Identify and implement AI/automation solutions to improve program execution
Requirements
- ✓Bachelor's or Master's degree in Biomedical, Mechanical, or Electrical Engineering
- ✓5+ years of program management or technical leadership experience in medical device industry
- ✓5+ years leading cross-functional NPI programs with proven success bringing products to market
- ✓Product Life Cycle Management experience with focus on process optimization
- ✓Strong understanding of medical device regulatory requirements (FDA, ISO, EU MDR)
- ✓Experience leading contract manufacturer qualification and onboarding programs
- ✓Experience coordinating complex programs with multiple stakeholders
- ✓Demonstrated ability to manage program schedules and drive execution
- ✓Experience working in matrix organizations with external partners
- ✓Strong written and verbal communication skills
- ✓Strategic thinking with ability to balance compliance, technical feasibility, and business objectives
- ✓Proficiency with program management tools and methodologies
- ✓Data-driven mindset with ability to leverage analytics and automation
- ✓Experience with AI-powered project management platforms
- ✓Comfort operating in fast-moving, ambiguous environments
Benefits
- ★A stimulating, fast-paced environment with lots of room for creativity
- ★Career development and growth with a competitive salary
- ★Opportunity to work with a talented team on innovative healthcare solutions
- ★Flexible environment with unlimited vacation and remote work options
- ★Access to health and well-being program
- ★Comprehensive benefits package including health insurance, meal allowance, and equity shares
