OrthAlign, Inc., a Smart Technologies, growing medical device company, has an immediate opening for a Manufacturing Engineering Technician I supporting sustaining engineering activities, including but not limited to: validation testing, data collection, non-conformance investigation, and CAPA activities. This role interacts directly with R&D, Quality, and Operations teams in an effort to deliver products that fulfill OrthAlign’s Quality Management System and good manufacturing practices per FDA and International Regulatory Standards.
- Identify and troubleshoot process, material, or equipment problems recommending solutions to engineers and operators
- Develop, assemble, procure, or modify existing and/or new tooling, fixtures, and equipment to ensure efficient production methods
- Assist Manufacturing Engineers with revisions and improvements to parts, manufacturing methods and procedures, including writing change orders
- Assist with hands on training of manufacturing employees on new products, tooling, equipment, and process revisions
- Write and execute protocols/reports, IQ/OQ/PQ/PPQs
- Execute and support IQ/OQ/PQ/PPQs
- Perform OPS support activities (NCMRs, CAPAs, and/or PDs)
- Perform production builds
- At least 1 year of work experience and your high school diploma (BS/BA degree preferred)
- Basic experience using Microsoft Office – Word, Excel, PowerPoint
- Experience using basic hand and power tools
- Experience using general test equipment including DMM, drop gauges, calipers, etc.
- Some experience with medical devices would be helpful
- Ability to read mechanical drawings and specifications
- Willingness and capability to take ownership of projects and drive them to a successful conclusion
- Hands on - get it done ability and attitude
- Analytical and organizational skills with the ability to solve problems
- Ability to initiate and manage time and resources effectively
- Ability to apply sound judgment when making decisions and communicating with peers and management
- Ability to think out of the box and pivot as needed
- Ability to prioritize multiple tasks
- Strong written and verbal communication skills
- Innovative products
- Awesome benefits
- Great coworkers
- An evolving, engaging culture and workplace
It is an exciting time at OrthAlign - make your next career move with us!
Please note we are unable to provide any type of sponsorship at this time.