Aditi Consulting · 18 hours ago
Subject Matter Expert Risk Management
Mansfield, MA, United States
Full-time
Onsite
Senior Level
$56.60/hr - $76.60/hr
5+ years expAditi Consulting is seeking a Subject Matter Expert in Risk Management within the Design Quality Assurance team. The role involves performing gap assessments and collaborating with cross-functional teams to execute and report usability and risk management activities, particularly in support of EU MDR remediation projects.
AppsConsultingInformation TechnologySoftware Engineering
Responsibilities
Perform thorough gap assessment of existing usability and risk management documentation against EU MDR requirements and relevant standards, such as ISO 14971:2019 and IEC 62366-1:2015
Provide risk management leadership, expertise, guidance, and supervision throughout the remediation project
Development of efficient and robust processes, procedures, practice, tools and technology to support continuous improvement in risk management
Leads development and implementation of key performance indicators and metrics for the risk management process
Support the post market surveillance team by creating Health Impact Assessments and Health Hazard Evaluations
Qualification
Required
Bachelor's Degree in Engineering (Mechanical, Chemical, Biomedical, Electrical)
5-7 years of experience of working within a medical device industry with subject matter expertise in the application of Risk Management (ISO 14971:2019) for all classes of medical devices
Expertise in the application of statistical techniques to support the calculation of probabilities of hazardous situations occurring (p1)
Expertise in industry best practices and advances in Usability Engineering and Risk Management practices, processes, tools and technology
Preferred
Worker at an engineer level that will create content, developing design control
Need to have expertise in Risk and Risk Management
Know ISO 14971
Working knowledge of the usability standards
Protocol development
Understanding of statistical methods and techniques
Remediation of Risk management files and potentially creation of usability engineer files
Roll up their sleeves and work
Wants someone to fix the problem and not consult on what is wrong
Benefits
Medical
Dental
Vision benefits
Health savings accounts with qualified medical plan enrollment
10 paid days off
3 days paid bereavement leave
401(k) plan participation with employer match
Life and disability insurance
Commuter benefits
Dependent care flexible spending account
Accident insurance
Critical illness insurance
Hospital indemnity insurance
Accommodations and reimbursement for work travel
Discretionary performance or recognition bonus
Sick leave
Mobile phone reimbursement
Company
Aditi Consulting
Aditi Consulting is a firm that stays abreast of offering technological solutions, project management and digital transformation.
1001-5000 employees
H1B Sponsorship
Aditi Consulting has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (55)
2024 (44)
2023 (25)
2022 (26)
2021 (24)
2020 (30)
Funding
Current Stage
Late StageLeadership Team
Raja Narayana
President & CEO
Pradeep Singh
Chairman
Recent News
bloomberglaw.com
2025-10-16
Company data provided by crunchbase