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!