We are seeking a skilled professional to join our team. The ideal candidate will have a strong background in reliability engineering, particularly within the medical device industry. This role involves collaborating with cross-functional software teams, leading Failure Mode and Effects Analysis (FMEA) meetings, and managing risk documentation. The successful candidate will support the development of patient apps and work onsite with a flexible schedule.

Must Have:

Agile Software Development Lifecycle Design Failure Mode and Effect Analysis (DFMEA) Experience with ISO 14971 and medical device risk management Nice to Have: Agile Methodologies and Scrum Software Project Management Android App Development Clinical Experience IOS App Development Risk Management Responsibilities: Develop, coordinate, and conduct technical reliability studies and evaluations of engineering design concepts. Recommend design or test methods and statistical process control procedures to achieve required levels of product reliability. Complete risk analysis studies of new designs and processes. Compile and analyze performance reports and process control statistics. Ensure corrective measures meet acceptable reliability standards. Analyze preliminary plans and develop reliability engineering programs to achieve company, customer, and governmental agency reliability objectives. Propose changes in design or formulation to improve system and/or process reliability. Determine units and/or batches requiring environmental testing and specify the minimum number of samples for statistically valid data. Qualifications: Requires a University Degree and a minimum of 2 years of relevant experience in a highly regulated industry. Advanced degree holders with 0 years of experience will also be considered. Additional Information: Target start date for interviews: Beginning of August Position start date: ASAP Work schedule: Onsite with a minimum of 3 days a week in the office until Labor Day; 4 days a week in the office thereafter. No relocation assistance available.