Master Biomedical Engineering Jobs in Austin, TX

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The Product Safety and Compliance (PS&C) Manager - New Product Development (NPD) Programs reports to the Director, PS&C and is responsible for driving program-level compliance initiatives, monitoring regulatory operations, and ensuring alignment with internal safety guidelines and global health authority expectations. Additionally, the role supports inspection readiness, regulatory intelligence, audits, compliance analytics, and continuous improvement initiatives, helping to strengthen YETI's global regulatory compliance framework and ensuring proactive identification and mitigation of compliance risks. This role will serve as a subject matter expert within the PS&C team, collaborating with cross-functional stakeholders to manage the safety profile for YETI product(s) throughout their lifecycle, supporting the optimal development and execution of operational procedures and standards. Responsible for providing advanced scientific, technical, and analytical expertise and for leading and executing safety and benefit-risk management global strategy for YETI's expanding markets.

Key Responsibilities:

• Regulatory Compliance: Ensure product compliance including chemical compliance, with all relevant regulatory guidelines, such as those from US, EU, Japan, ASEAN, Korea, China MERCOSUR etc. for manufactured goods in consumer product space.
• Safety Surveillance and Risk Management: Continuously monitor product safety data, post-market surveillance, to identify potential safety signals.
• Data Analysis and Interpretation: Analyze safety data using statistical methods and data analysis tools to evaluate potential risks and make recommendations.
• Risk Mitigation: Develop and implement risk management plans to mitigate potential safety risks, including labeling updates and risk communication strategies in Asian Countries.
• Regulatory horizon mapping especially in YETI's global markets. Contribute to signal detection, evaluation, and management activities, including preparing and presenting safety assessments to stakeholders.
• Oversee, prepare and review safety and compliance-related documents, including test reports, risk management plans to support regulatory registrations of YETI products as needed.
• Build relationships with stakeholders internationally to drive alignment.
• Work closely with Product Development, Quality, Packaging, Legal and other teams to ensure product safety of YETI products.
• Define and document compliance requirements that enable global market access.
• Manage complex business risks across varying regulatory environments and navigate dependencies across global technical and non-technical teams.
• Managerial responsibilities within PS&C team.
• Provide training and guidance on stewardship, traceability, and compliance obligations.

Qualifications and Attributes:

• Bachelor's Degree in a health or science discipline, such as Chemistry, Environmental Science & Policy, Toxicology, Environmental Law, Reliability Engineering or a related field with 8+ years of experience with safety risk management processes and procedures
• Master's or Doctor of Philosophy (PhD) in a health or science discipline or Biomedical Engineering (or international equivalent) preferred
• A proven track record for leading the PS&C function for the introduction of products to new global markets, including the analysis and communication of local requirements, and implementation to support market entry.
• Ability to execute safety science strategy and intermediate analytic and scientific skills
• Ability to analyze safety concepts or concerns of diverse scope across multiple consumer product categories
• High-level understanding of chemical compliance to interpret data from a safety perspective. Able to support YETI's Restricted Substances List (RSL) program and RSL audit. Able to support Supplier audits for Food contact GMPs and GWPs
• Advanced knowledge of post market surveillance processes and regulatory requirements
• Ability and willingness to challenge current state, suggest alternative approaches to improve work practices, and commit to defined changes
• Fluent English with excellent written communication skills.
• Familiar with common international safety test standards utilized by industry such as ASTM, ISO, JIS etc. and be able to help build a compliance test protocol.
• Must have ability to read and interpret engineering drawings, Bill of materials and Bill of substances.
• Working knowledge of various office software including Microsoft Office, Box and Video Conferencing technologies. Able to support YETI's PLM system.
• Strong analytical and critical thinking skills
• Industry certifications such as SPSP, RAPS etc. are desirable but not mandatory
• Highly organized with strong attention to detail and follow-through
• Must be able to work independently with minimal supervision
• Strong communication skills and must be willing to take initiative to drive for solutions
• Strong teamwork with ability to collaborate within global environments where teams may be dispersed.

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Benefits & Perks:

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