SUMMARY: The Manager of Hardware Engineering at Natus, Neuro, will lead a group of electrical, firmware, and/or mechanical engineers working on the next-generation of neurodiagnostic devices for Natus’ EEG, PSG, EMG and ICP monitoring solutions. This role will oversee both full time and contract employees located in North America and India and be responsible for managing projects, processes and people involving the hardware engineering function. This role is expected to provide hands-on leadership, assess and develop talent, and ensure projects are staffed and budgeted appropriately.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Ensure that all direct reports are familiar with, trained on, and follow all Quality System procedures related to their jobs which can affect the quality of products or services provided to our customers and that changes to procedures are reviewed, approved and validated prior to implementation.
• Provide technical and functional leadership to the hardware development team across multiple engineering design locations.
• Bring industry best practices of product development and help navigate changing technologies and trends.
• Be a leader in DFX principles, including an emphasis on product reliability, COGs, and time to market.
• Collaborate with cross-functional stakeholders such as Marketing, QA/RA, Service, and Operations to ensure alignment on project scope, design control documentation, quality and schedule.
• Ensure team deliverables are of high quality and that they adhere to Natus QMS design controls. Drive hardware and firmware requirements and design documentation, design and development, and test protocols and execution.
• Review and approve hardware and firmware technical documents in accordance with design controls processes and best design practices. Participate in systems, hardware and cross-functional technical reviews.
• Hold task owners accountable for delivering on time and with high quality. Identify project risks proactively and corresponding countermeasures.
• 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.
• 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).

QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Bachelor’s degree in Electrical or Mechanical Engineering or related field. Master’s degree preferred.
• 5+ years’ experience leading hardware, mechanical and/or firmware development function within a heavily regulated industry, preferably medical devices.
• Experience leading hardware and/or firmware development for real time acquisition systems using industry leading FPGA, micro-controllers, analog circuitry and power design.
• Experience leading product development from requirements to final release / launch.
• Extensive experience working with global teams and offshore partners.
• Knowledge and application of FDA Quality System Regulations, ISO 13485, ISO 14971 and IEC 60601
• Demonstrated strong sense of urgency and ability to manage conflicts.

Travel Required: Minimal travel in and out of country (less than 25% of the time) is required.
EEO Statement: 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.
Accessibility: 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 to contact our Human Resources Department.

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