Manufacturing Engineering Technician

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.

YOU WILL

• 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).

YOU NEED

• 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)


• Basic knowledge of equipment and tooling design / validation, preferred


• Ability to learn, apply, and communicate technical product information and requirements


• Demonstrates initiative, urgency, and commitment to team and customer success


• Knowledgeable in CAD (e.g., SolidWorks), preferred


• Ability to perform assigned tasks independently while seeking guidance from Engineers and Managers as needed


• Ability to travel domestically to CM sites

WE OFFER

• Competitive compensation including bonus and equity


• Opportunities for career advancement


• Full benefits package


• An evolving, engaging culture and workplace


• Voted a Top Place to Work in Orange County!

It's an exciting time at OrthAlign - make your next career move with us!