Manufacturing Engineer

Description

Manufacturing Engineer I plays a foundational role in supporting the development, maintenance, and improvement of manufacturing processes. This position assists senior engineers in optimizing production methods, creating process documentation, troubleshooting process issues, and implementing continuous improvement initiatives. The Manufacturing Engineer I collaborates closely with production, quality, and design teams to ensure consistent quality, process reliability, and operational efficiency.

• Assist in developing clear and concise process documentation such as Process Instructions (PI), Manufacturing Instructions (MI), and Work Instructions (WI).
• Support process validation activities such as Installation Qualification (IQ), Operation Qualification (OQ), Process Qualification (PQ) and collect data to verify process capability.
• Collaborate with manufacturing and quality teams to resolve production issues and implement corrective actions.
• Assist in the design and improvement of tooling, fixtures, and equipment to improve efficiency and safety.
• Participate and assist in automation projects.
• Perform time studies, workflow evaluations, and process observations under supervision.
• Support Advanced Quality Planning activities including PPAP and FMEAs , control plans, and flow charts as assigned.
• Monitor process performance metrics such as yield and scrap and report variances to engineering leadership.
• Research and propose new methods or tools to improve existing processes under engineer guidance.
• Participate in troubleshooting and root cause analysis using structured problem-solving methods (5 Whys, Fishbone).
• Assist in maintaining Quality System documentation and compliance with ISO 13485 standards.
• Coordinate with cross-functional teams to support continuous improvement initiatives (Continuous Improvement Plans, Kaizen).
• Provide training to operators on new processes and updated work instructions as needed.
• Perform other duties as assigned to support the Engineering department and company objectives.

* Other duties as required in support of the department and the company*

The responsibilities of this role do not include supervising other employees.

Requirements

To succeed in this job, an individual must satisfactorily perform each essential job function. The requirements below represent the required knowledge, skill, and ability. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

• A bachelor’s degree in engineering/sciences or 5+ years of experience in a technical engineering role.
• Experience in a manufacturing or engineering environment is preferred.
• Experience in plastics, thermoforming, or similar manufacturing is preferred.
• Experience in medical device manufacturing is a plus.
• Exposure to Lean or Six Sigma methodologies is a plus.

• Lean or Six Sigma certification preferred but not required.

• Excellent verbal and written communication skills in English.
• Conversational skills in any other language is a plus.

• Basic arithmetic: add, subtract, multiply, and divide whole numbers, fractions, decimals, and percentages.
• Statistics:
  Interpret and analyze numerical data using statistical methods.
• Basic algebra:
  The ability to manipulate symbols and equations to find unknown values, express relationships, and model situations.
• Basic Geometry:
  The ability to understand and work with shapes, angles, lines, and planes.
• Basic Trigonometry:
  Understanding essential trigonometry functions and how they relate to engineering drawings and specifications.

• Proficient in MS Office Suite (Excel, Word, PowerPoint) and SharePoint.
• Basic understanding of CAD tools (Solid Works preferred).
• Familiarity with ERP systems.
• Familiarity with Lean and Six-Sigma concepts.
• Basic understanding of GD&T and blueprint reading.
• Strong analytical and troubleshooting skills.
• Knowledge of ISO 13485 quality systems preferred.
• Ability to collaborate with cross-functional teams effectively.
• Eager to learn, adapt, and take initiative under limited supervision.
• Reliable and flexible to work additional hours on short notice to complete orders or special projects to meet customer or internal demands.

As part of their job duties, the employee must sit for lengthy periods while operating a computer. They frequently use their hands to type, handle…