ICA, Inc. सार्वजनिक स्वास्थ्य, जैवचिकित्सीय अनुसंधान और प्रौद्योगिकी के संगम पर काम करती है। यह संघीय एजेंसियों को उन्नत डेटा, विश्लेषण और कृत्रिम बुद्धिमत्ता का उपयोग करके महत्वपूर्ण स्वास्थ्य पहलों को आगे बढ़ाने में सहायता करती है। इसकी टीमें अनुसंधान में तेजी लाने, मिशन-केंद्रित सलाहकार कार्य, प्रबंधन सेवाओं तथा अनुसंधान और विकास में सहयोग देती हैं और जटिल जानकारी तथा उभरती प्रौद्योगिकियों को स्वास्थ्य सेवा कार्यक्रमों के लिए व्यावहारिक समाधानों में बदलती हैं। SBA 8(a) कार्यक्रम में भागीदार के रूप में ICA इन क्षेत्रों में एकमात्र-स्रोत और प्रतिस्पर्धी सेट-असाइड अवसरों के लिए आवेदन करने की स्थिति में है।
Senior Biomedical Engineer, Medical Device Regulatory Review
Senior Biomedical Engineer supporting FDA medical-device submission reviews, safety assessments, and regulatory analysis for ICA, Inc. The role leads risk evaluation, reviewer requirements, real-world evidence protocols, and technical guidance in a remote Virginia-based position.
विवरण
- Lead cross-functional medical-device teams as a technical authority across the full product life cycle, from premarket review through postmarket surveillance
- Review medical-device submissions and records, including 510(k), De Novo, PMA, IDE, and postmarket filings
- Assess cross-disciplinary review issues for their impact on device safety, effectiveness, benefit-risk decisions, stakeholder communication, and resolution
- Analyze device types, regulatory pathways, and review divisions to identify recurring patterns, gaps, and improvement opportunities
- Create and maintain a repository of representative submissions and review precedents for reviewer support and requirements definition
- Establish alert categories, priorities, reviewer actions, and escalation procedures
- Assess alert relevance, false-positive and false-negative rates, evidence quality, usability, and reviewer workload
- Create and improve SOPs, real-world evidence review protocols, and device-review standards using analytical findings and current FDA guidance
- Lead or support device risk analyses covering hazard identification, risk estimation, and benefit-risk assessment
- Prepare and present research findings, technical reports, and recommendations to senior stakeholders and leadership
- Mentor junior engineers and analysts and provide technical direction, including feedback on their work products
- Follow established SOPs and maintain complete documentation of review activities
आवश्यकताएँ
- Bachelor's degree in Biomedical Engineering or a related field plus 8+ years of relevant medical-device experience, master's degree plus 6+ years, or PhD plus 3+ years
- Experience with medical-device regulatory review, regulatory affairs, quality assurance, clinical review, or another regulated discipline
- Working knowledge of FDA medical-device regulations, 510(k), De Novo, PMA, IDE, and applicable FDA guidance
- Working knowledge of medical-device quality and risk standards
- Experience analyzing complex clinical or performance datasets and assessing study design and data quality for device evidence
- Ability to lead projects, balance competing priorities under pressure, and deliver high-quality work with limited supervision
- Exceptional attention to detail and organizational ability
- Strong written and verbal communication skills for technical and non-technical audiences
- Ability to obtain and maintain a Public Trust clearance
- Familiarity with common medical-device review topics
- Familiarity with device postmarket and real-world data sources, including MAUDE, device registries, UDI data, and real-world evidence in submissions
- Experience supporting FDA, particularly CDRH, or other HHS agencies
- Experience working on federal government contracts
- Previous success working in a remote environment
- Experience developing SOPs, standards, or review protocols
- Experience mentoring or leading small teams
- Advanced degree or relevant certifications such as RAC or CQE
- Previous medical-device reviewer experience in regulatory review, regulatory affairs, quality assurance, clinical review, or related regulated documentation
- Strong understanding of medical-device submission documentation and review workflows
- Experience gathering requirements and collaborating directly with clients, reviewers, or other domain stakeholders
- Ability to turn complex domain needs into clear, testable product requirements
- Strong analytical, facilitation, documentation, and communication capabilities
- Software and technology expertise is not required
- Application and interview materials must be the applicant's original work; unauthorized AI-assisted technologies are prohibited
लाभ
- Employer-paid health insurance premiums, with three medical plans available
- Dental insurance
- Vision insurance
- Health Spending Account
- Flexible Spending Account
- Life and disability insurance
- 401(k) plan with company match
- Paid time off including vacation, sick leave, and holidays
- Education and professional development assistance
- Remote work from anywhere in the continental United States