Manufacturing Engineering Technician

OrthAlign, Inc.; Irvine (CA); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Bonus and equity

Full benefits package

Career advancement

Top Place to Work in Orange County

Job summary

OrthAlign, Inc. is seeking an on-site Manufacturing Engineering Technician in Irvine, CA to support production, validation, and process improvements for medical devices.

You will work with cross-functional teams under Engineers and Managers, handling validation IQ/OQ/PQ, change orders, and documentation per SOPs. The role emphasizes hands-on assembly, testing, and documentation, with opportunities for growth within the manufacturing engineering team.

Qualifications

• High school diploma or equivalent; associate or bachelor’s preferred.
• Basic engineering technician skills in a medical device environment.
• Proficiency with MS Office and clear written/verbal communication.
• Attention to detail with the ability to work independently and in teams.
• Knowledge of ISO 13485 regulations is a plus.

Responsibilities

• Support and troubleshoot production issues, and help develop processes and fixtures.
• Coordinate builds and related training for engineering and production.
• Assist validation activities, IQ/OQ/PQ, and create validation reports.
• Support design control documents and manufacturing procedures.
• Plan process validation activities in collaboration with engineers.
• Provide routine technical support for manufactured products.

Skills

Engineering basics

MS Office proficiency

Detail oriented

Team collaboration

Medical device knowledge

ISO 13485 knowledge

CAD SolidWorks

Independent with guidance

Domestic travel ability

Education

High school diploma or equivalent

Associate or Bachelor preferred

Tools

SolidWorks

Basic hand tools

MS Office

Job description

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. This hands-on role is on-site, not remote or hybrid.

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!

Out of state candidates will not be considered.