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Experience the excitement of working in a growing and innovative company. Sentinelle is home to dedicated people committed to developing leading edge MRI products and software.
We thank you for your interest, but only those applicants selected for an interview will be contacted.
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Systems Engineer
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Reporting to the VP Engineering, the Systems Engineer will drive product development efforts by measuring, controlling and communicating product specifications, performance and interface characteristics.
Responsibilities
- Participate in innovative new product development projects, which integrate mechanical, electrical and software elements.
- Drive product testing and certification efforts.
- Plan, execute and maintain technical file for each product.
- Provide input to new designs to ensure they meet end user and regulatory requirements.
- Lead risk management, verification and validation activities and test plans.
- Co-ordinate testing at major medical OEMs' facilities.
- Provide project support and/or leadership on the introduction of new products and product modifications.
- Evaluate the design of new systems as a whole, encompassing mechanical, electrical and software elements.
- Support engineering change control process (design change validation and verification, BOM generation, process definition, etc.).
- Perform gap analyses and audits of technical files.
- Project management of verification and validation plan, ensuring on-time execution.
- Implement corrective actions to address process issues.
- Contribute improvements to company product development processes.
- Provide input into new designs to ensure regulatory compliance.
- Ensure environmental stewardship standards are upheld (RoHS, WEEE standards, etc).
- Work with large vendors and testing houses to interpret ambiguous product requirements.
- Some travel required within North America and overseas (2-6 short trips per year).
- Perform other duties/special projects as assigned.
Requirements
- Minimum 3 years experience in a product development environment.
- Experience with Verification and Validation test planning and execution.
- Engineering or science university degree.
- Excellent verbal and written communication skills.
- Able to work under time constraints.
- Proven project management skills.
Desired
- Mechanical manufacturing experience.
- P.Eng.
- Working knowledge of ISO 13485 and FDA regulations.
- Experience with medical devices.
- Project management experience
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