Manufacturing Engineering Technician

OrthAlign Inc.•Irvine, CA

1d•Onsite

About The Position

The Manufacturing Engineering Technician supports manufacturing engineering activities, including validation testing, data collection, non-conformance and complaint investigations, process and production-line improvements, process development, and design transfers. The role collaborates with cross-functional teams to support commercially available products and new product development for internal and external customers. Tasks and activities are performed under the guidance of Engineers and Managers.

Requirements

Basic engineering technician skills and experience, preferably in a medical device environment, and a high school diploma or equivalent (Associate or Bachelor degree preferred)
Basic proficiency using MS Office Suite (e.g., Word, Excel, PowerPoint)
Basic written and verbal communication skills
Results-oriented with appropriate urgency and follow-up
Ability to work as a collaborative team member as well as independently
Excellent attention to detail and ability to produce high-quality work
Strong organizational skills and the ability to prioritize multiple tasks
Experience using basic hand and power tools
Basic experience with medical device products and manufacturing operations, preferably including knowledge of regulations governing the manufacturing of medical device products (ISO 13485)
Ability to learn, apply, and communicate technical product information and requirements
Demonstrates initiative, urgency, and commitment to team and customer success
Ability to perform assigned tasks independently while seeking guidance from Engineers and Managers as needed

Nice To Haves

Basic knowledge of equipment and tooling design / validation, preferred
Knowledgeable in CAD (e.g., SolidWorks), preferred
Ability to travel domestically to CM sites

Responsibilities

Collaborate with Engineering to support and troubleshoot production issues and processes, and develop and improve processes, equipment, and fixtures.
Coordinate and plan engineering and production builds, including build-related training.
Coordinate and assist execution of process validation activities, including IQ, OQ, and PQ, and collaborate with Engineers to develop validation protocols and reports.
Support design control deliverables relating to production and operations such as manufacturing procedures and travelers.
Coordinate and assist with planning process validation activities, including IQ, OQ, and PQ, and collaborate with Engineers to develop validation protocols and reports.
Provide ongoing routine technical support for manufactured commercial products.
Create and revise manufacturing procedures, inspection documents, process specifications, drawings, and related documentation through change orders (COs).
Investigate and support nonconforming product and complaint investigations.
Develop and execute calibration and preventive maintenance procedures for internal and external equipment.
Perform test methods according to instructions.
Assemble electromechanical and mechanical components according to instruction, and document each build in accordance with Standard Operating Procedures (SOPs).