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Company

Original Job Post

CooperSurgical · 3 days ago

Senior Risk Management Engineer

Trumbull, CT

Full-time

Onsite

Senior Level

$120K/yr - $171K/yr

8+ years exp

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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

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Risk ManagementISO 14971EU-MDREU 2017/745EU-IVDREU 2017/746CAPASCAPASCARNCMRRoot Cause InvestigationProduct Development StatisticsDesign of ExperimentsHypothesis TestingAnalysis of VarianceDesign VerificationValidation TestingProcess Validation TestingTest Method Validation

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

401(k)

Medical coverage

Parental leave

Fertility benefits

Paid time off for vacation, personal, sick, and holidays

Multiple other perks and benefits

Company

CooperSurgical

Glassdoor

3.3

CooperSurgical provides a full portfolio of medical and surgical products. It is a sub-organization of The Cooper Companies.

Founded in 1990

Trumbull, Connecticut, USA

1,001-5,000 employees

http://www.coopersurgical.com

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)

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Trends of Total Sponsorships

2023 (7)

2022 (13)

2021 (6)

2020 (5)