Medical Device Workflow & Validation Lead

Job not on LinkedIn

🔥 18 minutes ago

⚔️ Virginia – Remote

⚔️ Virginia – Remote

💵 $130k - $160k / year

⏰ Full Time

🟠 Senior

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ICA, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

📦 Logistics

📣 Marketing

Healthcare • Logistics • Marketing

ICA, Inc. is a trusted partner and innovative force in transforming public health through advanced data, technology, and close collaboration with federal agencies. The company specializes in driving transformational changes through biomedical research, enhancing public health initiatives, and supporting critical research acceleration with NextGen solutions. With a focus on advanced data analytics, AI deployment, and healthcare research, ICA empowers federal agencies to achieve their missions and deliver better health outcomes. As a participant in the SBA 8(a) business development program, ICA is eligible for sole-source and competitive set-aside contracts, particularly excelling in the domains of management, advisory, and research and development.

📋 Description

• Build strong working relationships with client reviewers and establish a regular, structured feedback process. • Lead discovery and validation sessions using prototypes and working software. • Translate reviewer needs into workflows, business rules, user stories, and measurable acceptance criteria. • Validate proposed requirements and workflows before development begins. • Partner with the Senior Product Manager to ensure requirements are accurate from a medical-device review perspective. • Define meaningful alert categories, priorities, reviewer actions, and escalation paths. • Evaluate alert relevance, false positives, false negatives, evidence quality, usability, and reviewer effort. • Test completed capabilities from a reviewer’s perspective and identify missing requirements, confusing behavior, unsupported conclusions, and workflow gaps. • Lead client demonstrations, user acceptance testing, feedback capture, and acceptance or signoff. • Maintain traceability from the original client's needs through requirements, validation, and approval. • Improve domain understanding across product, engineering, data science, and leadership teams.

🎯 Requirements

• Previous experience as a medical-device reviewer with experience in medical-device regulatory review, regulatory affairs, quality assurance, clinical review, or related regulated-document field. • Strong understanding of medical-device submission documentation and review processes. • Experience gathering requirements and working directly with clients, reviewers, or other domain stakeholders. • Ability to translate complex domain needs into clear, testable product requirements. • Experience conducting user acceptance testing or structured software validation. • Ability to identify missing evidence, unsupported conclusions, workflow gaps, and unintended consequences. • Strong analytical, facilitation, documentation, and communication skills. • Credibility and confidence when working with client domain experts. • Comfort collaborating with product managers, engineers, data scientists, and UX teams. • Must be authorized to work in the United States and have lived in the US for 3 or more consecutive years. • Must be able and willing to obtain a Public Trust Clearance

🏖️ Benefits

• Health Insurance - 100% employer-paid premiums – ICA covers the full cost of one of three offered medical plans • Dental Insurance • Vision insurance • Health Spending Account • Flexible Spending Account • Life and Disability insurance • 401(k) plan with company match • Paid Time Off (Vacation, Sick Leave and Holidays) • Education and Professional Development Assistance • Remote work from anywhere within the continental United States