Manufacturing Engineer (medical Device)

Manufacturing Engineer

Design and develop manufacturing processes, tooling, and fixtures to meet daily production schedules while enhancing productivity and product quality. Interpret and validate manufacturing processes and documentation according to required specifications. Troubleshoot and resolve issues or defects in the manufacturing process using hands-on skills and assessment of manufacturing machine programs. Apply lean manufacturing concepts and manufacturing flow to define, maintain, and continuously improve process steps necessary for creating customer products and processes. Enhance current manufacturing processes improvements under FDA design control and ISO change control guidelines. Analyze and plan workflow, space requirements, and equipment layout to improve manufacturing efficiency.

Design and develop efficient manufacturing processes, tooling, and fixtures.

Interpret and validate manufacturing processes and documentation.

Troubleshoot and resolve manufacturing issues and defects.

Apply lean manufacturing concepts to improve process steps.

Enhance manufacturing processes under FDA and ISO guidelines.

Analyze workflow, space requirements, and equipment layout for efficiency.

Proficiency in manufacturing engineering.

Knowledge of ISO and ISO standards.

Familiarity with design control processes including verification, validation, and design history files.

Experience with documentation updates throughout the product lifecycle.

Understanding of IQ, OQ, PQ validation cycles.

Ability to support CAPA and update SOPs.

Expertise in lean manufacturing, tooling, machining, and continuous improvement.

Experience in machining and tooling.

Capability for continuous improvement.

The team operates in a startup-like environment where flexibility is key. Engineers may work on a project for 9–10 months and then be reassigned, requiring adaptability and comfort with shifting priorities. Experience with new product development and sustaining engineering is highly valued. Engineers will work directly with production operators and equipment such as CNC machines and presses. Training on proprietary equipment will be provided. The workplace fosters a family-friendly culture with bonding activities and celebrates cultural diversity through events and international menus. Innovation is encouraged, with a focus on contributing to cutting-edge dental technologies.

This is a Permanent position based out of Irvine, California.

The pay range for this position is $60320.00 - $101920.00/yr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision• Critical Illness, Accident, and Hospital• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available• Life Insurance (Voluntary Life & AD&D for the employee and dependents)• Short and long-term disability• Health Spending Account (HSA)• Transportation benefits• Employee Assistance Program• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Irvine, CA.

This position is anticipated to close on Oct 1, 2025.