IVD Product Development Associate – Entry Level

Volt; Martinez (CA); On-site; USD 29,000 - 35,000; Full time

Benefits offered by this job

Health, dental & vision insurance

401(k)

Paid time off

Job summary

Volt is hiring an Associate Product Development Scientist in Pacheco, California. The role focuses on facilitating product development projects, drafting design outputs, and assisting with technical documentation throughout the PDLC across R&D, Manufacturing, QC, QA, and Marketing.

The candidate will support GMP-compliant activities, work with cross-functional teams, and help organize lab documentation and reagent inventory.

Qualifications

• Bachelor's degree in a scientific or technical field required.
• 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.
• Product development experience within an IVD, biotechnology, or regulated laboratory environment.
• Familiarity with GMP requirements.
• Experience with technical documentation and document control.
• Ability to work cross-functionally with R&D, Manufacturing, QC, QA, and Marketing.

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 (PDLC) 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

R&D experience

IVD development

Design Controls & QSR

ISO13485/IVDR/MDSAP

Verbal & written communication

Presenting complex info

Product development in IVD/biotech

GMP familiarity

Technical documentation & control

Cross-functional collaboration

Education

Bachelor's degree in a scientific or technical field

Job description

Volt is hiring an Associate Product Development Scientist in Pacheco, California. The role focuses on facilitating product development projects, drafting design outputs, and assisting with technical documentation throughout the PDLC across R&D, Manufacturing, QC, QA, and Marketing.

The candidate will support GMP-compliant activities, work with cross-functional teams, and help organize lab documentation and reagent inventory.