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Medical Engineer - Oakville, ON, Canada - Kinsley Power Systems
Description
The Senior Sustaining Engineer is a crucial team member, who will lead product engineering and continuous improvement efforts, as well as, provide key voice-of-manufacturing and voice-of-customer feedback to guide new product designs, in the maintenance and sustainment of Natus' Neuro products.
This engineer will be the focal person for all technical and product sustaining issues in manufacturing, depot and field service, and for providing project management and technical leadership for changes, enhancements, and extensions of current products.
This role will provide technical leadership and mentoring to the greater Sustaining Engineering team and act as a technical consultant to support medical device issues and our network of stakeholders.
The successful candidate must be highly organized with prior experience in manufacturing sustaining roles including robust knowledge of mechanical, electrical, systems, and test engineering, and will use these strengths to help drive issue resolution in collaboration with cross-function teams.
dealing with everything that arises during the years of manufacturing a product such as component obsolescence, design changes required to improve performance/aesthetics/marketability/etc., quality concerns (yield improvement), product cost improvement, field issue investigations, etc.
including mechanical and/or electrical changes.Serve as the next-level of technical support for all product design-related matters related to released manufactured products and purchased components.
Investigate and resolve corrective and preventative actions using appropriate problem-solving techniques (DMAIC, FMEA, Ishikawa, 5-Whys, etc.).Support the implementation and maintenance of processes utilized in internal and external manufacturing, and depot repair and field service activities.
Prevent and/or respond to production stoppages due to supplier, process, or quality related matters.Drive continuous improvement and Value Engineering initiatives on released product.
Lead team efforts aimed toward improving customer satisfaction, product quality improvement, manufacturing yield improvement, reducing product variability, and reducing the cost of goods sold.
Provide engineering support for component obsolescence issues.Provide engineering support for product compliance and safety (IEC 60601, REACH, ROHS, CE, etc.).
Support change management across Natus Neuro's product lines, including drafting and coordinating the implementation of Engineering Change Orders.
Deliver medical device design documentation compliant with FDA design controls, good documentation practices, ISO 9001, and ISO Maintain medical device Design History Files and Device Master Records.
Support the development, change, and release of design documentation according to the Natus Quality Management System, including design artifacts such as BOMs, drawings, pFMEAs, dFMEAs, work instructions, and manufacturing procedures.
Bachelor's degree an accredited, four-year university or college in electrical, mechanical, systems, or biomedical engineering, or similar degree.
5+ years of sustaining engineering experience, preferably in the medical device industry manufacturing electro-mechanical products.Strong project management and organizational skills.
Ability to work with electronics, PCs and operating systems (understanding and proficiency), and MS Office applications including MS Project
Ability to read schematics and other electrical/electronic engineering documentation.
Experience with LabView or other test software language/platforms;
Knowledge of regulatory requirements in medical device industry;
Experience in FDA Quality System Regulations, Current Good Manufacturing Practices, risk management (ISO 14971], and Quality Management Systems for Medical Devices [ISO 13485];
Experience in human factors engineering and usability engineering for medical devices [IEC , IEC 62366, ANSI/AAMI HE75] and medical device safety standards [IEC 60601].
AgileTravel Required: 15% domestic and/or international travel on an as needed basis
7 paid holidays + 2 floating holidays of your choosing
Natus Medical Incorporated is recognized by healthcare providers globally as the source for solutions to screen, diagnose and treat disorders of the brain, neural pathways and sensory nervous system .
Our vision is to deliver innovative and trusted solutions to advance the standard of care and improve patient outcomes and quality of life.
Natus products are used in hospitals, clinics and laboratories worldwide.Natus Medical is an equal opportunity employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, disability, sexual orientation, gender identity, or any other protected status.
Natus is committed to creating an inclusive environment that accommodates all individuals, including those with disabilities.We support the goals of the Accessibility for Ontarians with Disabilities Acts (AODA) and have established policies, procedures and practices which adhere to the accessibility standards set out in the AODA.
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