Sr. Reliability Engineer

Sr. Reliability Engineer

Provide reliability engineering support to new product development and continuous improvement of commercially released medical devices. Responsible for technical assessments and compliance activities to ensure that reliability and safety are proactively designed into our products, that potential risks are analyzed and controlled, and that product/system performance is quantifiably predicted. Upgrade legacy test systems, developing comprehensive work instructions and tools to streamline the transition to new systems for both engineering and technician teams. Provide support in assessing the impact of post commercialization changes to products. Responsible for hardware and software development and qualification for automated battery testing equipment. Conduct electrical performance testing of primary and rechargeable batteries in implantable medical devices. Perform comprehensive risk management activities, including Design Failure Mode and Effects Analysis (DFMEA), Process Failure Mode and Effects Analysis (PFMEA), and Root Cause Analysis. Handle post-market product complaints, failure investigations, Non-Conforming Material Records (NCMR), and Corrective Action Preventative Actions (CAPA). Characterize process reliability using Gage R & R, Variable and Attribute Test Method Validation, Confidence and Tolerance Limits studies, and Capability & Normality Assessments, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Develop Statistical Process Control (SPC) charts and Out of Control Action Plans (OCAP) for critical processes. Generate deliverables for pre-market product development, including Product Performance Specifications, Design Verification and Validation, Design Transfer, and Usability and Human Factor Engineering. Perform data analysis and reporting using T-test, ANOVA, regression modeling, hypothesis testing, and Design of Experiments (DOE) tools in JMP, Minitab, R, or Python. Manage SQL/MongoDB database queries for battery performance testing in customized repositories. Ensure compliance with medical device regulations, including FDA 21 CFR 820, ISO 13485, ISO 9001, and ISO 14971.

Master's Degree in Mechanical Engineering, Electrical Engineering, Industrial Engineering, or Biomedical Engineering or related engineering field and two (2) years of experience as a manufacturing or reliability engineer. Must possess at least two (2) years' experience with each of the following: Electrical performance testing of batteries in implantable medical devices; Hardware and software development and qualification for automated battery testing equipment; Risk management, Design and Process FMEA, and Root Cause Analysis; Post-market product complaints, failure investigations, NCMR, and CAPA; Characterize process reliability using Gage R & R, Variable and Attribute Test Method Validation, Confidence and Tolerance Limits studies, and Capability & Normality Assessments, and IQ/OQ/PQ; SPC charts and OCAP; Pre-market product development, including Product Performance Specifications, Design Verification and Validation, Design Transfer, and Usability and Human Factor Engineering; T-test, ANOVA, regression modeling, DOE tools in JMP/Minitab, and R/Python; SQL/MongoDB database queries; and FDA 21 CFR 820, ISO 13485, ISO 9001, and ISO 14971.

Salary: $108,000 to $159,600 per year