Medical Device Workflow & Validation Lead (Remote, Continental United States)

ICA.ai; Oregon; Híbrido; USD 120.000 - 180.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health Insurance

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, H

Education and Professional Development

Remote work within continental US

Descripción de la vacante

ICA, Inc. is seeking a Medical Device Workflow & Validation Lead to translate reviewer needs into actionable product requirements and lead client demonstrations.

You will validate features from a medical-device perspective and ensure alerts, evidence, and workflows provide genuine value with minimal reviewer burden. You will collaborate with product managers, engineers, and data scientists, maintaining traceability from client needs to validation and approval.

Formación

• Experience in medical-device regulatory review or related regulated-document fields.
• Strong understanding of medical-device submission documentation and review processes.
• Experience gathering requirements with clients and domain stakeholders.
• Ability to translate complex domain needs into testable product requirements.
• Experience conducting user acceptance testing or software validation.
• Identify missing evidence, workflow gaps, and unintended consequences.
• Strong analytical, facilitation, documentation, and communication skills.
• Credibility when working with client domain experts.
• Comfort collaborating with product managers, engineers, data scientists, and UX teams.
• Authorized to work in the United States and willing to obtain Public Trust Clearance.

Responsabilidades

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

Conocimientos

Regulatory review

Client interaction

Requirements gathering

UAT experience

Data analysis

Facilitation

Communication

Educación

Bachelor's degree

Descripción del empleo

About ICA, Inc.ICA, Inc. is a rapidly growing company, located in the D.C./Metro area. We were founded in 2009 to assist government clients with evaluating and achieving their objectives. We have become a trusted advisor helping our clients by offering cutting-edge innovation and solutions to complex projects. Our small company has grown significantly, and we're overjoyed at the opportunity to expand yet again!We are results-focused and have a proven track record supporting federal agencies and large government services primes in three main areas: Research and Data Analysis, Advanced-Data Science, and Strategic Services. We currently support multiple analytics and research programs across HHS.At ICA, we believe our success starts with our people. We foster a collaborative "one team" environment where work-life balance isn't just talked about - it's prioritized. We're building dynamic, highly skilled teams in a welcoming and supportive atmosphere. If you're passionate about using your technical expertise to make a difference, we want to talk to you.We are looking for a Medical Device Workflow & Validation Lead to join our growing team!

ABOUT THE ROLE:

We are hiring a Medical Device Workflow & Validation Lead that helps to represent the reviewer's perspective across our document intelligence platform, including product development and client delivery. You will help us understand how reviewers work, translate their needs into clear requirements, validate features from a domain perspective, and lead client demonstrations and user acceptance. This role is responsible for ensuring that alerts, evidence, and workflows provide genuine value without creating unnecessary reviewer burden or presenting automated findings as regulatory conclusions

KEY RESPONSIBILITIES:

• 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.

REQUIRED QUALIFICATIONS:

• 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

USE OF AI ASSITIVE TECHNOLOGY

All application materials must be your own original work, and interviews must be completed independently. Use of AI-generated content in applications or AI assistance during interviews will result in disqualification.

BENEFITS:

We invest in our team members so you can live your best life professionally and personally, offering a competitive salary and 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

LOCATION & TELEWORK

This is a remote position following Eastern Standard Time (EST). Candidates residing in the DMV area preferred.

ADDITIONAL INFORMATION:

ICA is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, gender identity or expression, national origin, genetics, disability status, protected veteran status, age, or any other characteristic protected by state, federal or local laws.This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.