A Senior Manufacturing Engineer is needed for a medical technology company focused on the repair, regeneration and replacement of soft and hard tissue in the Austin, TX area. This Senior Manufacturing Engineer role requires medical device experience to independently lead complex, global site and manufacturing transfer projects, ensuring technical readiness, comprehensive IQ/OQ/PQ validation, and strict adherence to FDA/ISO 13485 quality and compliance standards.
location: Austin, Texas
job type: Contract
salary: $39.28 - 46.42 per hour
work hours: 8am to 5pm
education: Bachelors
responsibilities:
- Leads the planning and execution of manufacturing transfers across a global network.
- Executes end-to-end manufacturing and site transfer projects, including planning, risk assessment, validation, and handover.
- Coordinates technical readiness, validation activities, and process documentation for smooth transitions.
- Coordinates all technical documentation, process flows, and equipment readiness at both sending and receiving sites.
- Supports process and equipment validation (IQ/OQ/PQ) and ensures compliance with FDA and ISO 13485 requirements.
- Partners cross-functionally with Quality, Regulatory, Supply Chain, Manufacturing, and R&D.
- Leads root cause analysis and technical problem-solving during the transfer lifecycle.
- Prepares and maintains project documentation, including validation protocols, reports, and change control packages.
- Communicates project progress, risks, and mitigation strategies to stakeholders.
- Captures and shares lessons learned to improve future transfer processes.
- Must have a proven track record leading or supporting site/manufacturing transfers or new product launches.
- Requires strong knowledge of process validation, change control, and manufacturing documentation.
- Must have excellent problem-solving, communication, and organizational skills.
- Requires the ability to work independently and drive results with minimal supervision.
- Preferred experience includes orthopedic products, lean manufacturing, Six Sigma, and proficiency with ERP, PLM, or MES systems.
- Requires a Bachelor's degree in engineering, science, or a related discipline.
- Requires a minimum of 4 years of experience in medical device or other regulated industries.
qualifications:
- Experience level: Experienced
- Education: Bachelors
skills:
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
