LanceSoft
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
- Agile Methodologies and Scrum Software Project Management
- Android App Development
- Clinical Experience
- IOS App Development
- Risk Management
- 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.
- 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.
- 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.