Natus Medical is a leading manufacturer of medical devices for the Newborn Care, Neurology, Sleep, Hearing and Balance markets since 1989. Natus products are used in hospitals, clinics and laboratories worldwide. Our mission is to improve outcomes and patient care in target markets through innovative screening, diagnostic and treatment solutions.
The Systems Engineer is responsible for the design and requirements specification, usability engineering, risk management, and compliance engineering of medical electrical systems used in Neurology, Audiology, and Newborn Care products. You can expect to be involved in all phases of the product lifecycle, for both new product introductions and maintenance of existing products.
In this job, you will:
Contribute to the design, analysis, and testing of medical electrical systems from product conception through early product shipment. This includes specification, testing and documenting components, assemblies, cables and sub-systems. You can expect to integrate them into a system where safety, function, appearance, reliability and cost are all optimized.
Develop user and product requirements and specifications for medical devices, software, and systems
Establish traceability between design inputs, design outputs, and verification and validation
Coordinate with software developers, hardware engineers and mechanical engineers to ensure optimal performance of the system
Integrate custom-design medical devices and software with third-party components into fully functional systems
Contribute to risk management related activities and usability testing
Participate in quality improvement, complaints investigation, change control, and safety assessment processes
Contribute to harmonizing the company’s various medical device platforms by converging system architecture and reusing components as well as design and test practices (product line engineering)
May work in a lead designer role or lead projects involving cross-functional teams on new product development programs.
Stay up-to-date and follow all Quality System procedures related to this job, which can affect the quality of products or services provided to our customers.
Travel: up to 25% travel to Natus sites, domestic and international
Bachelor’s degree in Engineering or Science; Master’s degree is an asset
Minimum five years’ relevant experience and/or training related to systems engineering
Knowledge of medical device technology, applicable quality and safety standards, and regulations
Demonstrated ability to deal with a fast-paced environment, high levels of ambiguity, multiple concurrent projects, and conflicting assignments
Demonstrated initiative, attention to detail, customer focus, and commitment to ongoing process improvement
Experience with requirements specification and traceability
Knowledge of information technology: PCs, servers, software, and databases
Knowledge of product lifecycle management
Experience with project management a plus
The employee must occasionally lift and/or move up to 25 pounds
Natus offers competitive salaries, comprehensive benefit package that starts after 90 days of employment, paid holidays, generous paid time off plan (2 weeks to start, 7 sick days) and tuition reimbursement up to $5,000 annually.
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. Should you require any accommodation throughout the recruitment process please do not hesitate contacting our Human Resources Department.
At this time we do not require agency assistance.