Product Safety & Regulatory Compliance Engineer

ITW

1d

About The Position

The Product Safety & Regulatory Compliance Engineer serves in a consultative capacity on MTS product safety & regulatory compliance and product qualification activities to ensure compliance with national and international product safety regulatory requirements in the company’s product designs. Assist in the development of MTS product safety & regulatory policies and procedures. Represent MTS in pertinent international technical societies. Serves in a consultative capacity regarding worldwide response to product injury incidents. Train MTS staff on usage of systems and safety engineering for regulatory compliance.

Requirements

• BS degree in Engineering with 9 years related experience working in and coordinating cross functional engineering teams including electrical, mechanical, software, and manufacturing disciplines.
• Proven ability to successfully guide international safety and regulatory compliance in complex technical development projects.
• Proven ability to build relationships, lead cross-functional teams, and build consensus among development team members.
• Strong working knowledge of worldwide directives and standards (EN), including LVD, EMC, PED, and MD, ATEX, ASME standards, WEEE, RoHS, China CCC, TUV and other third party certification agencies.
• Able to perform the following functions:
• Functional analysis of engineered systems
• Risk assessment & FMEA of complex products
• Identification & interpretation of applicable international safety and regulatory standards.
• Guide product architecture development for efficient safety & regulatory compliance
• Lead product accident response teams for risk mitigation
• Lead legal, operations, and safety groups in product risk assessment and management
• Generate corporate standards, procedures, and tools for product safety and compliance
• Direct and Develop training, tools, and coaching to other staff for safety & regulatory compliance engineering
• Negotiate with international governing bodies on product and accident safety and regulatory compliance issues.
• Manage product safety development process.
• Define standards for product reliability analysis, FMECA, man rated system safety standards and approval procedures, and safety critical system configuration

Responsibilities

• Assist in the development of corporate policy & procedures for product safety and regulatory compliance: Evaluate and interpret US and foreign government regulations and standards to provide guidance for corporate compliance strategy and risk management.
• Assist in the development and implementation of policies, procedures, and tools to manage worldwide compliance to applicable product safety and regulatory requirements.
• Provide guidance to senior management regarding corporate compliance matters.
• Provide technical direction and communication across engineering, contracts, and legal to ensure understanding, cooperation and coordination, resulting in compliant practices/procedures.
• Assist in the development of MTS business process and procedures for product safety and regulatory compliance to ISO, AS, and CE standards.
• Conduct periodic audits to ensure compliance to established company policies and procedures.
• Guide product development teams on product safety & regulatory compliance: Evaluate and interpret US and foreign government regulations to provide technical design guidance for product development teams.
• Review proposed customer terms and conditions; advise product teams on impact of referenced standards and options for compliance or re-negotiation.
• Guide pursuit teams on contractual risk management with clarification of customer terms and conditions, with referenced standards and regulations, and with other applicable international standards which should be brought into play for a particular pursuit.
• Educate and train MTS staff on achieving safety and regulatory compliance.
• Assist in the development of MTS Test product safety and regulatory procedures and tools, train staff on their use.
• Tailor and adapt available industry standards and tools to enable MTS staff to better manage legal and operational risks of our manufactured systems.
• Assist in the development of tools and processes to enable other engineers to work on safety and regulatory issues in their projects with a reasonable level of autonomy.
• Develop methodology and processes for product test plans, and ensure effective validation testing for compliance to applicable safety & regulatory requirements.
• Serves as an engineering team leader and technical expert to resolve compliance-related matters, including incident resolution.
• Conduct or assist in internal investigations and analysis of any suspected non-compliant product / incident.
• Define and/or assist in definition of corrective action as necessary.
• Serve as primary contact and negotiator with international regulatory bodies as required for developmental systems, accident response, and policy development.
• Guide post incident investigation and problem resolution, advise corporate on risk exposures, follow up with action plans for related systems when warranted

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level