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CooperSurgical · 3 days ago
Senior Risk Management Engineer
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Health CareMedical Device
Insider Connection @CooperSurgical
Responsibilities
Review and evaluate scientific and technical data for product safety and performance.
Create and maintain product risk management files that align with regulatory standards, lead risk assessments for reported clinical issues, assess production or post-production trends to identify potential safety or performance issues, and participate in CAPA investigations or actions for medical device risk management, production safety, and implementation of risk control measures.
Create, evaluate, and validate product-related test methods.
100% remote work permitted.
Qualification
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Required
Master’s degree in Industrial Management, Engineering, or related field of study, plus 8 years of experience in regulatory requirements and standards for the development, approval, release, and maintenance of medical device / in-vitro diagnostic device products (21 CFR 820, ISO 13485, EU-MDD/MDR/IVDR)
8 years of risk management experience in a medical device or pharmaceutical environment (ISO 14971)
5 years of experience with remediation to EU-MDR (EU 2017/745, EU-IVDR, EU 2017/746 requirements. 5 years of experience with CAPA, sCAPA, SCAR, NCMR, and root cause investigation
3 years of experience with product development statistics including the design of experiments, hypothesis testing, analysis of variance, design verification and validation testing, process validation testing, and test method validation
Benefits
Medical coverage
401(k)
Parental leave
Fertility benefits
Paid time off for vacation, personal, sick, and holidays
Company
CooperSurgical
![company-logo](https://images.crunchbase.com/image/upload/t_cb-default-original/v1466148506/zxcpivdujobxuddkoeuh.png)
CooperSurgical provides a full portfolio of medical and surgical products. It is a sub-organization of The Cooper Companies.
H1B Sponsorship
CooperSurgical 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
Trends of Total Sponsorships
2023 (7)
2022 (13)
2021 (6)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Recent News
2024-02-10
Business Wire India
2023-09-20
Company data provided by crunchbase