TalentBurst, an Inc 5000 company · 2 months ago
US - Manufacturing Engineer-Sr
Austin, TX
Full-time
Onsite
Mid, Senior Level
$45/hr - $47/hr
4+ years expTalentBurst, an Inc 5000 company, is seeking a Senior Manufacturing Engineer to join their U.S. Orthopedics team. In this role, you will lead complex site and manufacturing transfer projects to ensure orthopedic products are manufactured and delivered with excellence.
RecruitingStaffing Agency
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
Support 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
Qualification
Required
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
Experience with orthopedic implants, instruments, or precision assembly
Familiarity with lean manufacturing and Six Sigma methodologies
Proficiency with ERP, PLM, or MES systems
Company
TalentBurst, an Inc 5000 company
Founded in 2002, TalentBurst is an MBE and JCC certified firm that provides award winning solutions globally.
1001-5000 employees
H1B Sponsorship
TalentBurst, an Inc 5000 company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2023 (7)
2021 (1)
2020 (4)
Funding
Current Stage
Late StageLeadership Team
Jamie Jacobs (she/her)
Sr Vice President of Strategic Partnerships and DE&I/ESG Council
Recent News
2025-11-19
Seattle TechFlash
2025-04-17
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