R&D, Tech Entry
About The Position
The R&D, Tech Entry role assists with product development, design control, technical documentation, laboratory activities, and cross-functional product development processes. The position supports development of new reagent products and helps monitor their progress through the Product Development Life Cycle (PDLC), coordinating internally with Reagent R&D and externally with Manufacturing, QC, QA, and Marketing to identify potential obstacles. The role also supports compliance with GMP requirements and helps maintain antibody raw material inventory in R&D. The position is full time, follows a day shift, and does not require travel. No prior experience is required. The full-time equivalent pay range is $25.42–$39.72 per hour, with eligibility for bonus, stock, and benefits.
Requirements
- Understanding of IVD development, including Design Controls, Quality System Regulations, and ISO 13485 and MDSAP requirements.
- High-level verbal and written communication skills and the ability to effectively present complex information.
- No prior experience required.
Responsibilities
- Facilitate product development projects.
- Draft Design Outputs for review by the Manager, Product Design.
- Assist with technical document review, including individual test records, data sheet revisions, product labeling, SOPs, and other design output documentation.
- Assist in editing product data sheets and revising departmental procedures.
- Revise documents related to product implementations and discontinuations.
- Participate in selected routine laboratory activities, including drafting purchase requisitions and ordering selected laboratory supplies.
- Monitor the progress of new reagent products through the Product Development Life Cycle (PDLC), both within Reagent R&D and with Manufacturing, QC, QA, and Marketing, to identify potential obstacles.
- Comply with GMP requirements and assist the Product Development Team with new product development, including organizing test results, drafting and proofreading documentation, scanning slides, and drafting grading forms.
- Assist in oversight of antibody raw material inventory in R&D.
Benefits
- Eligibility for bonus, stock, and benefits.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
No Education Listed
