Associate Product Development Scientist

Job Overview:

Associate Product Development Scientist will support IVD/diagnostic product development in a regulated laboratory environment. The role focuses on R&D support, technical documentation, Design Controls, product lifecycle tracking, GMP compliance, and coordination with R&D, Manufacturing, QC, QA, and Marketing teams.

Key Responsibilities:

• Support and coordinate product development projects within a regulated environment.
• Draft and review technical documentation, including test records, data sheets, SOPs, product labeling, and design-output documents.
• Edit product specifications/data sheets and assist with departmental procedure updates.
• Support documentation related to product launches, implementations, and discontinuations.
• Monitor new reagent products throughout the Product Development Life Cycle (PDLC).
• Work cross-functionally with R&D, Manufacturing, QC, QA, and Marketing teams.
• Review and organize test results and assist with preparation of product-development documentation.
• Identify potential issues that could impact product-development timelines and coordinate with appropriate teams.
• Support GMP-compliant product development activities.
• Assist with laboratory activities, purchasing of laboratory supplies, and antibody/raw-material inventory management.

Required Qualifications:

• Bachelor's degree in a scientific or technical field; Associate's degree is acceptable.
• 0-3 years of related R&D or laboratory experience/training.
• Understanding of IVD (In Vitro Diagnostics) product development.
• Knowledge of Design Controls and Quality System Regulations.
• Familiarity with ISO 13485, IVDR, and/or MDSAP requirements.
• Strong written and verbal communication skills.
• Ability to review, organize, and communicate technical information.

Preferred Experience:

• Product development experience in IVD, biotechnology, diagnostics, medical devices, or a regulated laboratory environment.
• Familiarity with GMP/cGMP requirements.
• Experience with technical documentation and document control.
• Experience working with cross-functional teams such as R&D, Manufacturing, QC, QA, and Marketing.
• Strong attention to detail and organizational skills.

Dexian stands at the forefront of Talent + Technology solutions with a presence spanning more than 70 locations worldwide and a team exceeding 10,000 professionals. As one of the largest technology and professional staffing companies and one of the largest minority-owned staffing companies in the United States, Dexian combines over 30 years of industry expertise with cutting-edge technologies to deliver comprehensive global services and support.

Dexian connects the right talent and the right technology with the right organizations to deliver trajectory-changing results that help everyone achieve their ambitions and goals. To learn more, please visit https://dexian.com/.

Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.