Design Assurance Scientist

IMMY•Norman, OK

About The Position

Job Purpose Independent execution of verification and validation (V&V) activities, ensuring regulatory alignment, data integrity, and lifecycle oversight. Leads analytical studies and usability assessments, coordinates cross-functional collaboration, and supports post-market DA activities.

Requirements

Bachelor’s or master’s in biology, chemistry, or related field.
1-2 years of experience in biotech related role.
Experience in testing immunoassays and/or molecular assays.
Strong technical writing, protocol development, and report generation skills.
Ability to work independently and lead studies.

Nice To Haves

Experience in IVD product development lifecycle.
Experience with assay development, verification, validation, or analytical testing.
Competency in statistical analysis.
Familiarity with working in a regulated environment (e.g., ISO 13485, ISO 14971, FDA 21 CFR Part 820, IVDR).

Responsibilities

Lead and execute analytical performance studies (precision, LoD, specificity, stability) and flex studies; Develop and review protocols.
Co-lead or support development of V&V plans, including acceptance criteria, specimen sourcing, and integration with clinical validation.
Lead formative usability studies; support summative studies.
Oversee risk management activities, mapping hazards to verification and validation activities and IFU claims.
Analyze and interpret data using appropriate statistical methods, ensuring rigor, reproducibility, and traceability.
Draft and review study reports, ensuring full documentation ensuring compliance with QMS-controlled systems and DHF requirements.
Assess design changes for impact on product performance, verification needs, and residual risks.
Collaborate with Product Development, Clinical Affairs, Regulatory, Quality Assurance, Project Management, and Business Development to align studies with regulatory and commercial objectives.
Support post-market activities by assessing field issues, contributing to CAPAs, and recommending additional studies.
Ensure training and competency of operators involved in study execution.
Supervision of DA technicians.