Program Manager, Material Compliance

Job Summary

The Material Compliance Program Manager is responsible for moderately difficult assignments in maintaining compliance systems such as Agile PG&C, UDI data collection and upload tools, and all compliance issues related to Global Material restrictions & reporting regulations for electronic products and medical devices.  Applicable regulations include but are not limited to RoHS, China RoHS, REACH, and Conflict Minerals. The Material Compliance Program Manager must be able to work closely with multiple departments in analyzing product material and advising them on methods of integrating compliance requirements. 

Duties & Responsibilities

• Ensure compliance systems are accurate and up to date.
• Investigate, analyze, plan, design, develop, validate, and implement material compliance procedures.
• UDI data capture and system upload.
• Devolving system applications for material compliance.
• Determine applicable standards and regulations for each product.
• Ensure all product regulatory requirements are identified and met.
• Must recognize and effectively address Global Material regulations.
• Expand and scrub product Bill of Materials to identify compliance gaps.
• Ability to work in cross-functional teams to implement or change product material, and/or processes, utilizing sound logic, rationale, and critical thinking to make decisions. 
• Coordinate with material suppliers to acquire all relevant compliance documentation.
• Work with other Material component Engineers to support their efforts to research and find documentation in order to bring products into material compliance. 
• Develop and maintain library of compliance documentation.
• Update compliance documentation with new and changing regulations.
• Prepare Declaration of Conformity for all relevant products.
• Keep current with regulations and changes.
• Preparing project compliance reports.
• Other assignments upon request.

Minimum & Preferred Qualifications and Experience

Minimum Qualifications

• Skilled in managing multiple tasks and projects.
• A high level of computer aptitude is required (MS Excel, Access, Word, PowerPoint, and Adobe).
• Experience with Global material restrictions, regulations (RoHS, China RoHS WEEE, REACH, Conflict Minerals, CE mark), and working knowledge of recognizing and effectively addressing the requirements.
• Experience with UDI data collection and UDI database submissions (GUDID, EUDAMED) 
• Strong written and verbal communication skills.
• Experience working with Bill of Materials.
• Good understanding of compliance systems such as Agile UDI data management, third party Roll up tools, and regulatory compliance databases.

Preferred Qualifications

• Three years’ experience in related field, preferably in material compliance environments.
• Management experience preferred.

Education

• Bachelor’s degree in related field required, preferably in Computer Science and Engineering.

Compensation

The anticipated range for this position is $95,000 - $135,000.  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 primarily works in an office environment. It requires frequent sitting, standing and walking.  Daily use of a computer and other computing and digital devices is required.  May stand for extended periods when facilitating meetings or walking in the facilities.  Some local travel is necessary, so the ability to operate a motor vehicle and maintain a valid Driver’s 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 accommodation may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.

For over thirty years, Masimo has been expanding the boundaries of noninvasive monitoring to improve patient outcomes and reduce the cost of care. Today, Masimo delivers a portfolio of hospital-trusted monitoring solutions to help increase patient safety, health, and wellness in the hospital and at home. When you join our team, you’ll be part of a culture that’s driven by passion, challenging the status quo, and making an impact in the lives of others.
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