Engineer, Regulatory & Product Safety

Job Summary

The Engineer, Regulatory and Product Safety is responsible for providing technical support for all aspects of regulatory and product safety throughout the product realization process. This position will handle projects from product inception, development, through manufacture and customer use. The incumbent provides support to ensure product meets defined safety standards and worldwide regulatory requirements.

Duties & Responsibilities

• Supports new product development through the application of safety standards and regulatory requirements;
• Supports developing Risk Analysis according to ISO 14971/ IEC 60601-1, 3^rd Edition;
• Provides support for various product certification agencies such as Intertek and external laboratories to obtain product safety certifications to applicable product safety standards (i.e., IEC 60601-1, 3^rd Edition, ISO 80601-2-61, etc.)
• Works to be knowledgeable in product safety standards
• Supports design reviews to applicable product safety standards.
• Responsible for creating in-house product safety reports aligned to IEC formats for pre-compliance design reviews.
• Support international and domestic filings/registrations, including updating technical files and design dossiers;
• Coordinate with international regulatory team members on product changes and regulatory notification/ approval requirements;
• Maintain up-to-date knowledge on international and domestic regulatory requirements;
• Update and Maintain EU Technical Documentation Summaries and Declaration of Conformities;
• Work with internal engineers on test protocols and test requirements as specified by regulatory health authorities and notified bodies;
• Provide guidance to other departments on IEC/ISO requirements (e.g., electrical safety, EMC, software)

Minimum & Preferred Qualifications and Experience

Minimum Qualifications

• 0-2 years of experience in product safety or equivalent;
• 0-2 years of experience with IEC 60601-1, 3^rd Edition;
• Proficiency with Microsoft Office applications;
• Strong communication, documentation, and problem-solving skills;

Preferred Qualifications

• Strong experience with IEC 60601-1, 3^rd Edition
• Experience generating IEC formatted test reports
• Experience in evaluating products to Product Safety Standards

Education

B.S. in Science or Engineering is required. M.S. in Science or Engineering is a plus.

Compensation: The anticipated range for this position is $67,000 - $85,000. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience.

Physical requirements/Work Environment

This position works in office, laboratory, and manufacturing environments. It requires frequent sitting, standing, and walking. He or she must also be able to lift up to 50 pounds. Daily use of computer and other computing and digital devices is required. He or she may stand for extended periods when facilitating meetings, walking in the facilities, and laboratory testing. Some international travel is required, so a valid international travel passport is required. Also, some local travel is necessary, so the ability to operate a motor vehicle and maintain a valid driver license is required.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with reals or perceived disabilities to perform the essential functions of the job described.