Prin H/W Reliability Engineer
Position Responsibilities:
· Lead component, subsystem, and system level reliability testing including life testing, demonstration testing, and HALT
· Lead field replacement component/subsystem strategies for new products
· Lead reliability improvements in Renal Care Solutions products by focusing on product design
· Work with cross-functional team to ensure Design for Reliability (DFR)
· Leverage reliability software tools to facilitate comprehensive set of reliability engineering modeling and analysis techniques to drive DFR
· Lead warranty cost optimization efforts for new products
· Post-market reliability : Analyze technical performance of the products in the field, lead root-cause analysis of failures, participate in CAPA investigations
Basic Qualifications:
· Bachelor of Engineering degree from a reputed university (Mech / Elec / Biomedical / Software)
· 12+ years of total work experience in design, test/V&V or quality/reliability roles in development of multidisciplinary technical products (biomedical, electromechanical, hardware-software, etc.)
· Experience working in all phases of the product development lifecycle (conceptualization, prototyping, design completion, commercial release, and cost-down/continuous improvement)
· 5+ years’ experience in the healthcare domain, with knowledge of medical device-related standards such as ISO 13485, US FDA’s 21 CFR 820, IEC 60601, etc. OR in a regulated industry such as aerospace or automotive
· Strong competency in statistics and expertise in analysis tools such as Excel, Minitab, Crystal Ball, Reliasoft suite of products or equivalent.
· Experience with returned product analysis
· Demonstrated ability to complete complex technical tasks on time, by providing strong technical leadership and guiding/coaching early-career engineers
· Excellent verbal and written communication skills, strong critical thinking and influencing skills
· Ability to work with cross-functional and cross-cultural global teams, and participate in early morning and/or late evening conference calls. Occasional travel, based on project needs.
Desired/Preferred Qualifications:
· Master’s degree in Engineering
· Relevant certifications (Reliability Practitioner, ASQ, Lean or Six-Sigma Green / Black Belt
· Formal training in development methodologies such as “Design of Experiments”
· Knowledge of de-rating analysis/ design margin analysis for electromechanical products
· Experience in software reliability testing methodologies
· Basic understanding of multiple technical fields. E.g. if you are a mechanical engineer, it would be a bonus to also have working knowledge of electrical/software/biomedical engineering
· Understanding of fluid circuits and flow control mechanisms (pumps, valves, heaters, sensors, etc.)
