Manufacturing Engineer I

Providien Thermoforming LLC; San Diego (CA); On-site; USD 70,000 - 90,000; Full time

Job summary

Providien Thermoforming LLC in San Diego seeks a Manufacturing Engineer I to support development, maintenance, and continuous improvement of manufacturing processes, collaborating with production, quality, and design teams. You will help create process instructions and work instructions, assist in process validation (IQ/OQ/PQ), lead time studies, and contribute to Kaizen events and ISO 13485 compliance.

This role offers exposure to tooling, automation projects, and a culture of teamwork and

Qualifications

• Bachelor’s degree in engineering or sciences, or 5+ years in a technical engineering role.
• Experience in manufacturing or engineering environment preferred.
• Experience in plastics, thermoforming, or medical device manufacturing is a plus.
• Lean or Six Sigma exposure is a plus.

Responsibilities

• Develop clear process documentation (PI/MI/WI).
• Support IQ/OQ/PQ validation and data collection for process capability.
• Collaborate with production and quality teams to resolve issues and implement corrective actions.
• Design and improve tooling, fixtures, and equipment for efficiency and safety.
• Participate in automation projects and continuous improvement initiatives.
• Conduct time studies and process observations under supervision.
• Maintain ISO 13485 documentation and compliance.

Skills

MS Office Suite

Analytical skills

Troubleshooting

Collaboration

Learning mindset

Initiative

Reliability

Flexibility

Education

Bachelor’s degree in engineering/sciences

5+ years of technical engineering experience

Tools

SolidWorks

ERP systems

SharePoint

Job description

Description

SUMMARY

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.

ESSENTIAL JOB FUNCTIONS

• 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*

SUPERVISOR RESPONSIBILITIES

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

Requirements

QUALIFICATIONS

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.

EDUCATION and EXPERIENCE

• 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.

CERTIFICATES, LICENSES, REGISTRATIONS

• Lean or Six Sigma certification preferred but not required.

LANGUAGE REQUIREMENTS

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

MATHEMATICAL SKILLS

• 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.

JOB SKILLS

• Proficient in MS Office Suite (Excel, Word, PowerPoint) and SharePoint.
• Basic understanding of CAD tools (SolidWorks 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.

PHYSICAL 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 objects, and communicate verbally. Additionally, they may need to stand, walk, reach, and occasionally lift objects weighing up to twenty (20) pounds. This role requires lifting, carrying, pushing, pulling, reaching overhead, reaching at or below shoulder level, and keyboarding. According to ADA regulations, reasonable accommodation will be provided to ensure that individuals with disabilities can perform the job’s essential functions.

WORK ENVIRONMENT

A work environment in a manufacturing plant is the physical and social setting where goods production occurs. Depending on the type of product, process, and plant, the work environment may vary in terms of noise, temperature, safety, and demand. Common characteristics of a work environment in a manufacturing plant are the use of machinery and exposure to hazards such as chemicals, heat, dust, or noise, with a culture of teamwork, communication, and continuous improvement.

ENVIRONMENTAL POLICY

Providien Thermoforming is fully committed to minimizing the environmental impact of its operations, activities, and products. To achieve this, we adhere to all applicable environmental regulations and laws, prevent pollution, and continuously improve our environmental performance in all our global operations. This is possible through an Environmental Management System that provides a framework for setting and reviewing our environmental objectives and targets. We aim to identify and reduce any negative environmental impact our business activities may have.

PERSONAL PROTECTIVE EQUIPMENT REQUIREMENTS

• ASTM F-2412-2005, ANSI Z41-1999, or ANSI Z41-1991 rated safety toe shoes in specific areas.
• Clear ANSI Z87.1 safety-rated glasses in specific areas.
• Hearing protection in specific locations.
• Ability to compile with JSA in specific areas.

TRAVEL

Approximately10% of travel is expected.