Position Details: Reliability Engineer-Process : ISO 13485

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

Education

• 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