TalentBurst, Inc. is hiring: US - Manufacturing Engineer-Sr in Austin
TalentBurst, Inc., Austin, AR, US
Job Description Job Description Manufacturing Engineer-Sr Austin TX, 78758 6 Months (Possible Extension) Description: We design and manufacture technology that takes the limits off living. Are you ready to apply your engineering expertise to work that truly makes a difference? Join our U.S. Orthopedics team as a Contract Senior Manufacturing Transfer Engineer and play a key role in ensuring our orthopedic products are manufactured and delivered with excellence. This is an exciting short-term opportunity for an experienced engineer to lead complex site and manufacturing transfer projects that directly impact patient outcomes. What You’ll Do : As a member of the U.S. Orthopedics Operations Engineering team, you’ll lead the planning and execution of manufacturing transfers across our global network. Y ou’ll coordinate technical readiness, validation activities, and process documentation to ensure smooth transitions between manufacturing sites—while maintaining world-class standards for quality, safety, and compliance. Key Responsibilities: • Execute end-to-end manufacturing and site transfer projects, including planning, risk assessment, validation, and handover. • Coordinate all technical documentation, process flows, and equipment readiness activities at both sending and receiving sites. • S upport process and equipment validation (IQ/OQ/PQ) and ensure compliance with FDA and ISO 13485 requirements. • Partner cross-functionally with Quality, Regulatory, Supply Chain, Manufacturing, and R&D to ensure alignment and readiness. • Lead root cause analysis and technical problem-solving throughout the transfer lifecycle. • Prepare and maintain project documentation, including validation protocols, reports, and change control packages. • Communicate project progress, risks, and mitigation strategies to stakeholders at all levels. • Capture and share lessons learned to continuously improve future transfer processes. What You’ll Need Success in this role requires technical expertise, attention to detail, and a collaborative mindset. You should be comfortable managing multiple priorities in a fast-paced, regulated environment. Required Qualifications: • Bachelor’s degree in engineering, science, or related discipline. • Minimum of 4 years of experience in medical device manufacturing or other regulated industries. • Proven track record leading or supporting site or manufacturing transfers. • Or, proven track record of new product launches into existing sites. • Strong knowledge of process validation, change control, and manufacturing documentation. • Excellent problem-solving, communication, and organizational skills. • Ability to work independently and drive results with minimal supervision. Preferred Qualifications: • Experience with orthopedic implants, instruments, or precision assembly. • Familiarity with lean manufacturing and Six Sigma methodologies. • Proficiency with ERP, PLM, or MES systems. TB_PH ZR Company Description Founded in 2002 by three former Monster.com executives; TalentBurst is an award-winning full-service Staffing Firm working directly with Fortune 500 companies in the US and Canada. We specialize in Contract and Contract to Permanent roles across many industries and have direct/contractual relationships with all our clients. Please visit our website or come meet us at our offices in Natick, MA, Miami, FL, Christiansburg, VA, Vineland, NJ, Houston, TX & downtown San Francisco, CA Company Description Founded in 2002 by three former Monster.com executives; TalentBurst is an award-winning full-service Staffing Firm working directly with Fortune 500 companies in the US and Canada. We specialize in Contract and Contract to Permanent roles across many industries and have direct/contractual relationships with all our clients. Please visit our website or come meet us at our offices in Natick, MA, Miami, FL, Christiansburg, VA, Vineland, NJ, Houston, TX & downtown San Francisco, CA