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Position Details: Reliability Engineer-Process : ISO 13485

Location: Milpitas, CA
Openings: 1


Job Title Reliability Engineer
Relevant Experience 
(in Yrs) 6+

Technical/Functional Skills 
Skills in the application of statistics, including experience with Minitab
Working skills in: inspection qualification methods, sampling plans, inspection techniques, process validation
Skills in process control & other process monitoring activities
Experience Required
Knowledge of statistical process control and other process monitoring methods and techniques 
Strong understanding of and experience in the application of statistics, including experience with Minitab
Knowledge of GR&R, inspection qualification methods, sampling plans, inspection techniques, critical attributes, process validation, trending methods, environmental monitoring, etc.

Roles & Responsibilities

Review plans (quality plan, risk management plan) and requirements (safety, functionality, regulatory) to ensure provisions for quality are addressed & resolved prior to product release
Work with R&D and the project team to develop, review and approve appropriate verifications (DVT) for both new design and changes to released product.
Perform statistical analysis of data and technical support for performing testing
Assess reliability in bench, lab, and/or clinical settings, producing full traceability of reliability assessment evidence to performance measures, metrics and requirements.
Develop reliability growth and verification test plans, accelerated testing methods, statistical data analysis methods and test equipment concepts to support product and subsystem reliability growth and evaluation.
Review and approve changes to designs/processes and assess impact on product and qualification status
Ensure team compliance of relevant safety regulations, QSRs, ISO Standards, MDD, and key FDA/MDD guidance documents
Ensure technical documentation meets requirements of the regulation such as ISO 13495 and FDA CFR820 

Generic Managerial Skills

Must have strong organizational, analytical and problem-solving skills
Must have keen time management skills
Ability to work in a team proactively, flexibly in an environment


B.S. in Engineering
Minimum 4 years of experience in Reliability Engineering. 2+ years of experience working with medical device products and in the healthcare industry

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