Senior Manufacturing/Hardware Engineer

3 weeks ago


Boston, Massachusetts, United States Leuko Labs Inc. Full time
Job Description

Leuko Labs Inc. is seeking a highly skilled Senior Manufacturing/Hardware Engineer to join our team. As a key member of our organization, you will be responsible for leading the execution of manufacturing operating plan milestones, driving productivity innovations, and ensuring product quality and stability of processes.

Key Responsibilities:

  • Lead, plan, and direct PointCheckTM product manufacturing transfer activities.
  • Develop and refine hardware engineering solutions (CAD/prototyping) to support manufacturing transfer.
  • Define and execute manufacturing strategies aligned with regulatory requirements and company objectives.
  • Manage strategic partnerships with medical device contract manufacturers and suppliers.
  • Ensure compliance with relevant regulatory standards and quality management systems.
  • Develop and implement metrics to measure performance and drive continuous improvement.
  • Collaborate with cross-functional teams to achieve business objectives.

Requirements:

  • Bachelor's or Master's degree in Engineering or Operations Management.
  • Advanced prototyping, CAD, and design review skills.
  • Experience working with contract manufacturers in the healthcare industry.
  • Strong knowledge of compliance regulations and quality management systems.
  • Excellent written, interpersonal, and presentation skills.

About Leuko Labs Inc.

Leuko Labs Inc. is a VC-backed company developing PointCheckTM, a non-invasive white blood cell monitoring device. Our mission is to empower patients and their loved ones by providing broad and immediate access to blood testing. We are committed to innovation, quality, and excellence in all aspects of our business.



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