Sunrise Systems, Inc. ยท 2 months ago
US - Manufacturing Engineer-Sr
Austin, TX
Full-time
Onsite
Mid, Senior Level
4+ years expSunrise Systems, Inc. is a company that designs and manufactures technology for the orthopedic field. They are seeking a Senior Manufacturing Engineer to lead complex manufacturing transfer projects, ensuring excellence in the production and delivery of orthopedic products.
Information Technology & Services
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
Sunrise Systems, Inc.
Sunrise Systems was founded in 1990 with a clear vision to deliver world-class staffing service solutions in all labor categories, including IT consulting and solutions; all with the commitment to provide service that exceeds expectations and become the most trusted name in the industry.
501-1000 employees
H1B Sponsorship
Sunrise Systems, Inc. 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
2024 (2)
2020 (2)
Funding
Current Stage
Late StageLeadership Team
Ruchi Hajra
Senior Account Manager/Client Servicing/Talent Acquisition Partner
Company data provided by crunchbase