New Product Introduction Manager

3 weeks ago

Melbourne, Victoria, Australia Saltworth Full time

Direct message the job poster from Saltworth

AI 'trailblazers'? I bypass fakers Land local, proven humans. The keepers Innovate. Lead. Build. Hire real 'sticky' tech people... #Melbourne…

NPI Manager / Product Consultant - Medical Device

  • Transform pregnancy and labour care through innovative medical hardware
  • Venture-backed Australian MedTech startup pioneering a patented Class I sterile consumable device that redefines mechanical labour induction
  • Pre-production phase, with prototyping underway and human clinical trials on the horizon.

Ready to help us shape the future of maternal health?

The Opportunity: a hands-on Medical Device Product Consultant (or NPI Manager) to accelerate our journey from pre-production to commercialisation. You'll bridge execution gaps, establish robust systems, and prepare us for regulatory compliance (TGA/FDA) as we transition to legal manufacturer status.

What You'll Do

  • Drive prototyping to trial manufacturing for human clinical trials
  • Design and implement an in-house Quality Management System (QMS)
  • Finalise production methodologies, focusing on polymers/plastics (injection/compression moulding expertise essential)
  • Develop scalable, compliant manufacturing and supply chain processes
  • Collaborate with biomedical engineers, designers, and key opinion leaders
  • Ensure documentation traceability for regulatory submissions

What You Bring

  • Proven experience commercialising MedTech hardware (Class I/II+ devices)
  • Expertise in polymer scaling (injection/compression moulding) and QMS setup
  • Regulatory fluency (ISO 13485, TGA/FDA)
  • Comfort wearing multiple hats in a resource-lean, fast-paced startup
  • Bonus: Sustainability know-how in packaging/logistics
  • ~0.4 FTE, flexible hours, remote-friendly
  • Potential for full-time role pre-market
  • Future equity consideration

Why Join Us?

Be part of a mission-driven team revolutionising women's health with cutting-edge MedTech. Your expertise will shape a product that impacts lives globally, with the chance to grow with us as we scale.

Seniority level
  • Seniority levelEntry level
Employment type
  • Employment typePart-time
Job function
  • Job functionEngineering and Information Technology
  • IndustriesIT Services and IT Consulting

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