Validation Specialist

We are seeking a Validation Specialist to support a cutting-edge medical device program within a neuroengineering environment. This role is focused on ensuring that complex therapy systems meet user needs and regulatory expectations through well‑defined, traceable validation processes. You’ll play a critical role in connecting user intent to system performance by building structured validation strategies, documentation, and evidence pathways during an active development phase.

This is a highly collaborative, detail‑oriented position ideal for someone who enjoys translating technical requirements into clear validation outcomes.

• Define validation strategies and techniques aligned to user needs for therapy systems
• Develop and document acceptance criteria for validation activities
• Author validation plans, protocols, reports, and summary documentation
• Execute and support validation studies, including capturing and analyzing evidence
• Partner with systems engineering, human factors, and clinical teams to align validation efforts
• Communicate validation progress, findings, and risks to cross‑functional stakeholders

• Bachelor’s degree in Biomedical Engineering, Systems Engineering, Human Factors, or related field
• Experience in a regulated medical device environment (FDA 21 CFR Part 820 design controls)
• Hands‑on experience with design verification and/or validation activities and documentation
• Strong ability to connect user needs, system requirements, and validation evidence
• Excellent written and verbal communication skills across technical and non‑technical teams
• Experience with tools such as Windchill RV&S, Codebeamer, or similar (preferred)
• Exposure to human factors, user studies, or qualitative validation methods (preferred)

Brooksource is an equal opportunity employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances.