What are the responsibilities and job description for the Quality Engineer 3 position at Cube Hub Inc.?
Description
Position Description: Remote opportunity for a Medical Device Risk Manager that will be leading a Risk Management Team focused on remediating existing Risk Management Files for the Digital Oncology portfolio. We are looking for candidates in Central and Eastern time zones.
Summary: Leads Risk Management efforts and processes for the Varian software Product portfolio, with a main focus on Varian’s Digital Oncology Information system (OIS) software products. Remediate existing clinical software Risk Management Files that include risk management plans, hazard analyses, risk assessments and post market surveillance. Collaborates as risk management file owner with healthcare software development teams to ensure the comprehensive implementation of risk control measures in the clinical software in accordance with Varian’s risk management procedure and international standard ISO 14971
Minimum Required Skills and Knowledge: Bachelor’s degree in Healthcare, Science or Engineering with several years of related experience. At least 5 years of relevant experience in medical device risk management or digital electronic health record system. At least 5 years of relevant experience in Healthcare Software Development. Knowledge in ISO 13485, ISO 14971, FDA CFR 820, EU 2017/745, IEC 62304, IEC 82304 and IEC/TR 80002-1. Medical Device Risk analysis, risk control measure evaluation, implementation and validation testing experience. Good written and verbal communication in English language. Strong interpersonal skills Knowledge and understanding of international safety standards for medical devices. Related experience with US Class II or III (EU class IIb or III) medical devices is highly desired. Related experience with Software as a Medical Device (SaMD), Risk analysis and Cybersecurity Risk management. Proficient in utilizing business tools such as: Outlook, Microsoft Office.
Vaccination Notice
Additional Details
Position Description: Remote opportunity for a Medical Device Risk Manager that will be leading a Risk Management Team focused on remediating existing Risk Management Files for the Digital Oncology portfolio. We are looking for candidates in Central and Eastern time zones.
Summary: Leads Risk Management efforts and processes for the Varian software Product portfolio, with a main focus on Varian’s Digital Oncology Information system (OIS) software products. Remediate existing clinical software Risk Management Files that include risk management plans, hazard analyses, risk assessments and post market surveillance. Collaborates as risk management file owner with healthcare software development teams to ensure the comprehensive implementation of risk control measures in the clinical software in accordance with Varian’s risk management procedure and international standard ISO 14971
Minimum Required Skills and Knowledge: Bachelor’s degree in Healthcare, Science or Engineering with several years of related experience. At least 5 years of relevant experience in medical device risk management or digital electronic health record system. At least 5 years of relevant experience in Healthcare Software Development. Knowledge in ISO 13485, ISO 14971, FDA CFR 820, EU 2017/745, IEC 62304, IEC 82304 and IEC/TR 80002-1. Medical Device Risk analysis, risk control measure evaluation, implementation and validation testing experience. Good written and verbal communication in English language. Strong interpersonal skills Knowledge and understanding of international safety standards for medical devices. Related experience with US Class II or III (EU class IIb or III) medical devices is highly desired. Related experience with Software as a Medical Device (SaMD), Risk analysis and Cybersecurity Risk management. Proficient in utilizing business tools such as: Outlook, Microsoft Office.
Vaccination Notice
Additional Details
- Quality Engineer 3|DC
- Does this worker qualify for overtime? : Yes
- Scorecard Category : Engineering
- Commercial Title : Software Medical Device Risk Manager
- Vaccination Notice : This position requires Contingent Workers to be fully vaccinated against COVID-19 unless they are granted a medical or religious exemption.
- Is this position for a pre-identified (PAYROLLED) candidate? : RECRUITED
- If this is a pre-identified (PAYROLLED) candidate, please see note below and provide the following: : Name: Email Address: Phone Number: Pay Rate: Please also attach the pre-identified candidate's resume
- Will this contingent worker require a computer or systems access or utilize a timeclock? : Yes
- Time System : Fieldglass
- Timeclock/Shift : NA - Time is not tracked in any system|NA
- Enter Shift Start and End Time : 9:00 a.m. - 5:00 p.m.
- Is there potential for this to convert to a full time position? : No
- Non-Employee Class : Temporary Agency Worker
- Will the worker be required to travel for Client? : No
- Is there potential for this assignment to be extended beyond 13 weeks? : Yes
- Type of assignment : Full-time
- Healthineers Vaccination Statement : Healthineers positions within applicable states require candidates to be fully vaccinated or obtain approval of special medical or religious exemption within three days of worker start date.Currently not applicable in the following states: Alabama, Florida, Iowa, Kansas, Montana, North Dakota, Tennessee, Texas, and Utah. States subject to change
