Manufacturing Engineer

NIHON KOHDEN OrangeMed; Santa Ana (CA); On-site; USD 70,000 - 100,000; Full time

Job summary

A medical device company is seeking a Manufacturing Engineer to provide engineering support and optimize manufacturing operations. The role involves generating documentation, analyzing production processes, and supporting continuous improvement initiatives. Candidates should possess a Bachelor's degree in engineering and have at least five years of relevant experience. The position offers an annual salary range of $70,000 to $100,000 and may require occasional travel and extended hours.

Qualifications

• Minimum five years of manufacturing experience in medical device or aerospace industry.
• Experience in regulated manufacturing environments.
• Prior experience with mechanical ventilators or similar medical devices is a plus.

Responsibilities

• Generate and update manufacturing documentation.
• Provide technical support for manufacturing cells.
• Analyze production processes and data.
• Review and calculate production costs.
• Support continuous improvement programs like Lean and Six Sigma.
• Assist with manufacturing process verification.

Skills

Technical writing

Problem-solving

Detail-oriented

Communication skills

Analytical skills

Proficiency in Microsoft Office

Education

Bachelor’s degree in mechanical, electrical or industrial engineering

Tools

Inspection and measurement instruments

Job description

The Manufacturing Engineer provides technical and engineering support to the manufacturing department. This role supports manufacturing operations through process optimization, problem-solving, and implementation of engineering solutions to improve efficiency, quality, and productivity.

Duties and Responsibilities

• Generates and updates manufacturing documentation like job travelers and device history records
• Provides technical support for all manufacturing cells.
• Analyze production processes, schedules, methods and other data to better understand future requirements needed for the manufacturing process
• Review and calculate labor, material and other production costs along with reviewing schedules and future production requirements to assist management in decision making
• Analyze and plan workflow, equipment placement and space requirements to improve manufacturing efficiency.
• Supports continuous improvement programs, such as Lean Manufacturing and Six Sigma, to drive process optimization and waste reduction.
• Assist with manufacturing process verification and validation testing and data collection as needed.
• Assist with the performance of failure investigations and complaint handling being processed through quality and manufacturing.
• Maintaining and developing the manufacturing processes, equipment, and tools.
• Perform other related functions as requested by management.

Qualifications

Education and Experience

• Bachelor’s degree in mechanical, electrical or industrial engineering required.
• At least five years of manufacturing experience within the medical device or aerospace industry.
• Experience supporting regulated manufacturing environments and quality systems is highly preferred.
• Prior experience with mechanical ventilators or similar electro-mechanical medical devices is a plus.

Skills & Abilities

• Strong technical writing and documentation skills.
• Ability to read and interpret engineering drawings, schematics, and technical specifications.
• Experience with inspection and measurement instruments including calipers, micrometers, and go/no-go gauges.
• Familiarity with testing and troubleshooting electronic and electro-mechanical equipment.
• Strong problem-solving and analytical skills with a focus on continuous improvement.
• Detail-oriented, well organized, and capable of managing multiple priorities.
• Effective written and verbal communication skills with the ability to collaborate across cross-functional teams.
• Proficiency in Microsoft Office applications including Word, Excel, and PowerPoint.

Compensation

The anticipated range for this position is $70,000.00 to $100,000.00 at an annual base. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, experience and location.

Working Conditions

• A Manufacturing Engineer usually works in the manufacturing environment which includes warehouse, receiving inspection, final configuration, and manufacturing areas.
• A Manufacturing Engineer may be required to travel occasionally.
• A Manufacturing Engineer works a standard work week but may be required to work some evenings and weekends to meet the needs of the company.

Physical Requirements

Must be able to type using the keyboard of a computer. Must be able to talk, listen and speak clearly on the telephone. Must be able to lift and carry up to 50 lbs.