TechLink Systems, Inc. · 1 day ago
Risk Management SME - VB2026
Mansfield, MA, US
Full-time
Hybrid
Senior Level
5+ years expTechLink Systems, Inc. is a national provider of staffing services. They are seeking a Risk Management Subject Matter Expert to perform gap assessments and lead risk management activities within the Design Quality Assurance team, focusing on EU MDR remediation projects.
Information TechnologySoftware EngineeringStaffing Agency
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
Company
TechLink Systems, Inc.
TechLink Systems is a national provider of staffing services with offices all over the USA as well as development and support centers globally.
201-500 employees
H1B Sponsorship
TechLink Systems, Inc. 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
2023 (1)
2021 (3)
2020 (3)
Funding
Current Stage
Growth StageLeadership Team
J
Jane Kim
CEO
Company data provided by crunchbase