Senior Engineer for Reliability in IVD
Infostride
Take the lead as a Senior Reliability Engineer for IVD products in Ottawa, Ontario. This exciting role emphasizes reliability strategies and compliance in the medical device arena. With over a decade of experience in product reliability engineering in MedTech, you will be instrumental in developing IVD devices that meet strict regulatory demands. Your role will involve leading DFMEA analyses, executing sophisticated HALT testing, and conducting pivotal lifecycle assessments to ensure optimal performance and compliance. Key Responsibilities:
- Develop and enforce reliability requirements for medical devices
- Lead risk assessment initiatives like DFMEA
- Design and implement HALT and HASS testing programs
- Conduct detailed life data analyses and report findings
- Ensure product compliance with regulated standards
- Minimum of 10 years in reliability engineering in MedTech
- In-depth knowledge of DFMEA and HALT methodologies
- Expertise in data analysis using Minitab or JMP
- Ability to design custom test setups
- Knowledge of IEC and FDA regulatory standards
Vacancy posted 8 days ago
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