R&D, Tech Entry
Core
Facilitates product development projects and drafts design outputs for review within the R&D team.
Role type
Entry-level R&D technician (product development)
Builds
New reagent products through the Product Development Life Cycle (PDLC)
Domain
In vitro diagnostics (IVD) / Life Sciences
Required skills
Understanding of IVD development, Design Controls, Quality System Regulations, ISO 13485, MDSAP requirements, Laboratory supply management, Document drafting and editing
Preferred skills
None stated
Technologies
None stated
Responsibilities
Drafts Design Outputs for review, Assists with technical document review including test records and SOPs, Participates in routine laboratory activities, Monitors progress of new reagent products through PDLC, Complies with GMP requirements, Assists in oversight of antibody raw material inventory
Seniority
Entry-level, no prior experience required