Reliability Engineer II jobs in United States
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Scalence L.L.C. · 1 month ago

Reliability Engineer II

Scalence L.L.C. is seeking a Reliability Engineer II to support reliability engineering activities for CAS products. This role involves developing and executing test methods, performing design verification, and collaborating with cross-functional teams on engineering projects.

Information Technology & Services

Responsibilities

Develop, set up, and execute Test Method Validation and Design Verification test methods
Prepare technical documentation including test reports, approvals, and related engineering summaries
Design/customize test fixtures or samples as needed
Conduct reliability studies, DOE setups, and risk analysis for new designs and processes
Analyze test data, performance results, and process control statistics; recommend corrective actions
Ensure reliability, compliance, and quality standards are met
Collaborate with cross-functional teams and support ongoing engineering projects

Qualification

Reliability Engineering expertiseDesign VerificationTest Method DevelopmentFDA 21 CFR Part 820ISO 13485Microsoft Office proficiencyCommunication skillsCross-functional teamwork

Required

Bachelor's degree in Engineering, Science, or a related technical field
Reliability Engineering expertise, specifically: Reliability testing, Design Verification, Test Method Development & Test Method Validation
Strong written and verbal communication skills
Ability to work effectively in cross-functional teams and independently with minimal supervision

Preferred

1–3 years of experience in the Medical Device industry
Knowledge of regulatory requirements: FDA 21 CFR Part 820, EU MDR (EU 217/745)
Familiarity with standards: ISO 13485, ISO 14971, IEC 60601
Proficiency with Microsoft Office (Word, Excel, PowerPoint, Access) and Windows OS

Company

Scalence L.L.C.

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Funding

Current Stage
Late Stage
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