Reliability Engineer
1 month ago
We are seeking a highly skilled Reliability Engineer to join our team at TEPHRA. As a key member of our engineering team, you will be responsible for ensuring the reliability and quality of our products.
Key Responsibilities:- Review and develop quality plans and risk management plans to ensure provisions for quality are addressed and resolved prior to product release.
- Work with R&D and project teams to develop, review, and approve verification plans for new designs and changes to released products.
- Perform statistical analysis of data and provide technical support for testing.
- Assess reliability in bench, lab, and 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 and processes, assessing their impact on product and qualification status.
- Ensure team compliance with relevant safety regulations, QSRs, ISO Standards, MDD, and key FDA/MDD guidance documents.
- Ensure technical documentation meets requirements of regulations such as ISO 13495 and FDA CFR820.
- B.S. in Engineering.
- Minimum 4 years of experience in Reliability Engineering, with 2+ years of experience working with medical device products and in the healthcare industry.
At TEPHRA, we offer a dynamic and challenging work environment, with opportunities for professional growth and development. We are committed to excellence and innovation, and we are seeking a talented and motivated individual to join our team.
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