Main Responsibilities 

• Execute DHF remediation related to Design Transfer, including DHR gap assessment, work instruction remediation, process FMEA, process validation, and other process controls
• Execute design transfer activities for modified designs.
• Implement sustaining design changes to existing products
• Conduct experimental tests and/or analysis and evaluate results
• Work closely with operations to investigate line-down situations; propose and execute resolutions to issues
• Communicate with suppliers regarding potential component specification issues
•  Execute process validations and test method validations
• Confirm compliance by staying up-to-date and following all quality system procedures related to this job, which can affect the quality or products or services provided to our customers
• Research electrical and/or mechanical solutions for simple to moderate sustaining engineering change requests
• Investigate and determine root cause of product failures resulting in complaints, NCRs, or other quality records
• Utilize company PLM tools and procedures, complete Engineering Change Orders accurately and following all appropriate design controls
• Travel: up to 10% domestic or international travel on a project need basis
• Location: This role can be based out of Natus Oakville or Ottawa site with hybrid flexibility. 100% Remote in Ontario may be considered. 

 Qualifications 

• Bachelor's degree in mechanical or electrical engineering field from four-year college or university required and at least five years' related experience in medical device industry
• Experience completing Corrective and Preventative Action (CAPA) and performing root cause analysis
• Knowledge and experience with electrical safety testing, such as IEC60601 compliance or similar, and establishing/validating such tests in a manufacturing environment is needed
• Familiar with good manufacturing practices (GMP) 
• Working knowledge of design engineering software packages such as schematic capture or mechanical drawing, or statistics software such as MiniTab
• Excellent computer skills, including Microsoft Project, Visio, and Office.
• Experience with PLM and Product Data Management (PDM) systems
• Analytical thinker with good interpersonal, leadership, and communication skills