Adecco Healthcare & Life Science is assisting a local client with their search for a Risk Management SME in Princeton, NJ. Apply today if you meet the qualifications listed below! + Location: Princeton, NJ + Duration: Temp-to-hire + Pay rate: $63/hour **Summary/Description:** This is a Subject Matter Expert role in Risk Management within the Design Quality Assurance team. The role involves performing gap assessments, planning, organizing, executing, and reporting all usability and risk management activities through collaboration with cross functional teams. This role is responsible for support of EU MDR remediation projects of varying scope and complexity. This individual will collaborate with internal design and development, regulatory affairs, medical affairs, and manufacturing engineering partners. **Essential Duties and Responsibilities** + To perform this job successfully, the individual must be able to perform each essential duty satisfactorily: + 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 **Qualifications/Experience Required:** + The requirements listed below are representative of the knowledge, skill, and/or ability required for this position. + 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 **Why work for Adecco?** + Weekly Pay + 401(k) Plan + Skills Training + Excellent medical, dental, and vision benefits Benefit offerings include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pay upon meeting eligibility criteria. IMPORTANT: This job is being recruited for by Adecco’s Medical and Science division, not your local Adecco Branch Office. For opportunities available at Adecco Medical and Science go to www.adeccousa.com/industries/medical-and-scienceEqual Opportunity Employer/Veterans/Disabled (http://www.adeccousa.com/industries/medical-and-scienceEqual%20Opportunity%20Employer/Veterans/Disabled) . To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit http://www.adeccousa.com/candidate-privacy/ . The Company will consider qualified applicants with arrest and conviction rec **Pay Details:** $63.00 per hour Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Equal Opportunity Employer/Veterans/Disabled To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.adecco.com/en-us/candidate-privacy The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: + The California Fair Chance Act + Los Angeles City Fair Chance Ordinance + Los Angeles County Fair Chance Ordinance for Employers + San Francisco Fair Chance Ordinance