Product Development Associate — IVD & GMP Focus

Lancesoft; Martinez (CA); On-site; USD 70,000 - 95,000; Full time

Job summary

LanceSoft is seeking a detail‑oriented R&D Support Associate to facilitate product development projects, review design outputs, and assist with technical documentation across the Product Development Life Cycle from R&D to Marketing.

The role requires a bachelor’s degree in a scientific or technical field, 0–3 years of related experience, and knowledge of IVD development, Design Controls, and GMP practices. Collaboration across cross‑functional teams is essential.

Qualifications

• Bachelor's degree in a scientific or technical field.
• 0–3 years of related R&D experience or training.
• Understanding of IVD development.
• Knowledge of Design Controls and Quality System Regulations.
• Familiarity with ISO 13485, IVDR, and MDSAP requirements.
• Strong verbal and written communication skills.
• Ability to effectively communicate and present complex information.

Responsibilities

• Facilitate and support product development projects.
• Draft design outputs for review by Product Design management.
• Assist with technical document review, including test records, data sheets, product labeling, SOPs, and design-output documentation.
• Edit product data sheets and assist with revisions to departmental procedures.
• Revise documentation associated with product implementations and discontinuations.
• Participate in routine laboratory activities, including preparation of purchase requisitions and ordering laboratory supplies.
• Monitor new reagent products through the Product Development Life Cycle across R&D, Manufacturing, QC, QA, and Marketing.
• Identify potential obstacles affecting product development timelines and coordinate with cross-functional teams.
• Support GMP-compliant product development activities.
• Organize test results and assist with drafting, proofreading, scanning, and preparation of product-development documentation.
• Assist with oversight of antibody raw material inventory within R&D.

Skills

Verbal communication

Written communication

Presentation skills

Education

Bachelor's degree in a scientific or technical field

Job description

LanceSoft is seeking a detail‑oriented R&D Support Associate to facilitate product development projects, review design outputs, and assist with technical documentation across the Product Development Life Cycle from R&D to Marketing.

The role requires a bachelor’s degree in a scientific or technical field, 0–3 years of related experience, and knowledge of IVD development, Design Controls, and GMP practices. Collaboration across cross‑functional teams is essential.