Manufacturing Process Specialist

4 weeks ago


Baltimore, Maryland, United States LifeSprout Full time
Job Summary:

The Manufacturing Technician will be responsible for following established manufacturing protocols to produce in-process material, components, and finished medical devices. This role requires a strong understanding of materials processing and machine operation, as well as the ability to execute on deliverables and manage milestones.

Key Responsibilities:
  • Produce composite materials using electrospinning, cryomilling, plasma treatment, and chemical processes.
  • Assist in collaborative research projects with other team members.
  • Create and refine work instructions and inspection procedures.
  • Design and conduct manufacturing investigations and trend analysis for trouble-shooting manufacturing concerns.
  • Conduct process validation investigations that confirm reproducibility, scale-up potential, and ongoing quality assurance with manufacturing procedures.
Requirements:
  • Undergraduate degree in chemistry, chemical engineering, materials science, biomedical engineering, or a related discipline with 0-2 years of experience in industry or academia or 2+ years in a medical device or pharmaceutical industry manufacturing environment.
  • Experience in materials processing and machine operation; beneficial if previous experience includes electrospinning, hydrogel synthesis, and/or surface modification.
  • Demonstrated ability to execute on deliverables and manage milestones.
Preferred Qualifications:
  • Previous experience working with work instructions and inspection procedures/processes, specifically within a cleanroom setting.
  • Previous experience in handling investigations, trend analysis, and/or CAPA analysis.
  • Working knowledge of GMP manufacturing processes, FDA and regulatory bodies, and quality systems.
  • Specific work or academic project experience in the soft tissue aesthetic and/or reconstructive arenas.
Eligibility to work in the U.S. is required.

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