Senior Compliance Engineer - Safety

JOB TITLE: Senior Compliance Engineer - Safety

Welcome to Natus Sensory

We are continuing to globally grow our business and are now looking to expand our team in Schaumburg, USA. Be part of this exciting journey right from the start!

Natus Sensory is a leading manufacturer of medical devices and software for a range of solutions, including eight sensory nervous systems. Our mission is to improve patient outcomes in target markets through innovative screening, diagnostic and treatment solutions. We manufacture and distribute a range of medical device products used in the diagnosis of human disorders of sensory system and neural pathways.

Location: Schaumburg, Illinois, USA.

About The role

As a Senior Compliance Engineer, focus on safety within our R&D department, you will lead the development and implementation of compliance strategies to ensure that our medical devices meet all applicable safety and regulatory standards throughout the product lifecycle. In this role, you will collaborate with cross-functional teams to define and implement compliance strategies, oversee testing and certification processes, and maintain up-to-date knowledge of global regulatory requirements. Your expertise will be crucial in identifying potential hazards, conducting risk assessments, and ensuring that our products adhere to the highest safety and quality standards.

Essential Duties and Responsibilities:

* Compliance Strategy and Education:

o Educate internal teams on international and North American (US/Canada) standards and regulations governing the manufacturing and distribution of Natus products, ensuring a comprehensive understanding of compliance requirements.

o Facilitate the approvals process to gain and maintain market access, acting as the subject matter expert to ensure product compliance throughout the product lifecycle.

* Design Verification and Testing:

o Apply extensive knowledge of principles and best practices to verify product design conformance to international and North American electrical and mechanical standards and regulations.

o Provide direction and support during compliance testing, collaborating with engineering teams and third-party laboratories to ensure accurate and thorough testing.

o Develop and execute test plans in coordination with design, quality, and test teams, ensuring all compliance aspects are thoroughly evaluated.

* Process Development and Improvement:

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

o Evaluate, recommend, procure, and maintain various processes, procedures, architectures, equipment, programs, instrumentation, and other technologies for continuous improvements in compliance or compliance testing.

* Data Analysis and Continuous Improvement:

o Assist design teams in analyzing acquired data and failures to provide actionable information, improving design quality and efficiency while ensuring compliance.

o Coordinate work activities with other engineers on development projects for new and existing products, properly documenting activities in accordance with best engineering practices, company procedures, and regulatory requirements.

* Cross-Functional Collaboration:

o Work closely with electrical and mechanical test engineers to ensure correct test processes and procedures are followed to gain and maintain product compliance.

o Lead and participate in technical review meetings, providing technical mentorship to junior engineers and continuously updating best practices and design methodologies.

Qualifications

* Education & Experience

o bachelor's degree in electrical engineering or a related field; a combination of education and experience will be considered.

o Minimum of 8 years of demonstrated experience in Electrical Engineering within heavily regulated industries, focusing on Product Compliance.

* Technical Expertise

o Proficiency in PCB fabrication and assembly best practices; experience with Altium Designer is preferred.

o Extensive experience with hardware and system testing compliance, particularly concerning IEC 60601-1 and IEC 60601-1-2 standards, encompassing EMC and electrical safety regulations.

o Proven ability to troubleshoot and resolve issues related to Safety and EMC compliance.

o Solid understanding of requirement drafting and interpretation, ensuring alignment with regulatory standards.

* Regulatory and Compliance Knowledge

o Familiarity with ISO 13485 and ISO 14971 standards, which are integral to medical device quality management and risk management systems.

o Knowledge of IEC 62304 for medical device software lifecycle processes and FDA review guidance is advantageous.

o Understanding of UL 94 and IEC 62133 standards related to flammability and battery safety, respectively.

* Additional Skills

o Experience with cable-to-board and board-to-board connectors, contributing to robust and reliable product designs.

o General knowledge of schematic capture and PCB layout tools is preferred, enhancing design accuracy and efficiency.

o Experience with medical device testing at accredited laboratories such as Intertek, UL, or TUV is a plus, ensuring adherence to industry standards.

We offer

* The role is a work-from-home remote position but can turn into a hybrid or physical presence in an office role in one of our US offices.

* Minimal travelling: less than 5%

* Collaborative and international environment with different cultures.

* English company language.

* Compensation and Benefits: Along with a competitive salary and bonus structure, we offer a comprehensive benefit package to start on day one of employment:

o Health Benefits,

o 401k match,

o 9 paid holidays including 2 "floating holidays" of your choosing,

o 4 weeks PTO,

o tuition reimbursement up to $5,000 annually and access to our Udemy online learning platform.

o the salary range is $106,000 - $148,000 USD annual to start based on experience/regional cost of living and 4% bonus.

EEO Statement

Natus Sensory 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.

Come Join Natus Sensory!