Job Description

Senior Compliance Engineer

Location: You can be based out of a Natus site or Remote in Canada

As a TEAMMATE:

As the Senior Compliance Engineer - Remote, you will build and leverage cross-functional relationships to bring together ideas, information, use cases, and industry analyses to develop best practices within the R&D organization for the entire product lines in the Natus Sensory platform. You will be a key analytical problem solver identifying root causes, evaluating optimal solutions, and recommending comprehensive upgrades to prevent future issues. You must be relentless about quality by thriving in a fast-paced environment and ensuring a project is complete and meets regulations and expectations.

What you\xe2\x80\x99ll get to do in this role:

Responsible for educating the business on all aspects of compliance with international and North America (US /Canada) standards / regulations governing the manufacturing and selling of Natus products.

Responsible for facilitating the approvals process to gain and maintain market access.

Act as the system expert assuring product compliance while designs meet functional requirements and design inputs throughout the product life: Involved earlier in the Project Requirement Definition process.

Possess and apply a broad knowledge of principles, best practices and procedures to verify product design conformance to international and North America (US/Canada) electrical and mechanical standards, regulations.

Provide direction and support during compliance testing, design, and sustainment : engineering teams in relation to compliance issues and 3rd party labs with respect to our product compliance testing.

Develop and execute test plans with design, quality, and test teams.

Work with Electrical and Mechanical Test Engineers to ensure the correct test processes and procedures are followed to gain and maintain product compliance.

Responsible for any equipment, processes, accreditation, documentation, or audits associated with internal certification, preliminary compliance and compliance testing.

Assist in designing and installing process sampling systems, procedures, statistical techniques, testing mechanisms, and equipment associated with compliance testing.

Assist the design teams in analyzing acquired data and failures in order to provide actionable information improving the design quality and efficiency and respecting the compliance.

E valuate, recommend, procure and maintain various processes, procedures, architecture, equipment, programs, instrumentation and other technologies for continuous improvements in compliance or compliance testing.

Travel: up to 25% domestic or international travel on project need basis

What we are looking for:

Bachelor\xe2\x80\x99s degree in electrical engineering or related field; a combination of education and experience can be considered

8 + years of successful demonstrated experience in Electrical Engineering in a heavily regulated industry with a focus on Product Compliance :

PCB fabrication and Assembly best practice : Altium is preferred.

Experience in Cable -to-board and board-to-board connector

Experience creating and executing compliance test plans.

Solid understanding of requirement drafting and interpretation

Significant experience with Hardware and System Testing compliance and knowledge of IEC 60601 -1 and IEC 60601-1-2: EMC and electrical safety regulations:

Able to troubleshoot and Solving problem with EMC/Safety

General knowledge of Schematic Capture and PBC Layout tools is preferred.

Significant experience with medical device testing (such as at Inter tek, UL or TUV) is a plus.

Knowledge of the following standards is preferred:

• ISO 13485

ISO 14971

IEC 62304

FDA review guidance

UL 94

IEC 62133

Compensation and Benefits: Natus offers a competitive salary, comprehensive benefit package that starts your first day, paid holidays, RRSP Match, paid time off plan (3 weeks vacation, 7 sick days each year), tuition reimbursement up to $5,000 annually, and Online Learning.

#INDNATUS

We are PASSIONATE about:

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.

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 contacting our Human Resources Department.

At this time we do not require agency assistance.

Come Join natUS!

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Natus Medical