Job Tittle: Manufacturing Engineer-Sr
Duration: 06 Months Contract
Location: Austin, TX
Job Summary:
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. You’ll coordinate technical readiness, validation activities, and process documentation to ensure smooth transitions between manufacturing sites.
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.
• 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.
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.
Job Description Overview: RiverWoods is currently looking for a Per Diem Healthcare Server/ Diet Aid to come and join our team! As a server, you will provide a high level of customer service to our residents in a friendly, clean and fun environment.Are ...
...vaccine experience preferred**** fast paced studies**** 10 site visits a month**~ The Senior CRA will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with...
...flexible hours, and unlimited earning potential. No prior experience is needed you can start earning immediately with our quick onboarding process. Position... ...~ Flexible Schedule Choose Your Hours ~ Fast Hiring Process Interview & Start in 2448 Hours What...
...Delivery Driver - Flexible Schedules & High-Performance Team Opportunity! NHBlacklabs Delivery LLC A proud Veteran-owned company... ...Drivers to join our dynamic crew! We're partnering with giants like Amazon to deliver packages safely and swiftly to homes and businesses...
...Well respected facility in Chicago is seeking a Spanish speaking Family or Adult NP/PA to join their team.~ Family / Adult Nurse... ...32 clinical hours over 4 days with 1 admin day (usually worked from home) and 1 Saturday a month 8a-5p ~100% outpatient~ Typically...