Manufacturing Engineer

Planet Pharma; Naperville (IL); On-site; USD 45,000 - 59,000; Full time

Job summary

Planet Pharma in Naperville, IL, is seeking a Manufacturing Engineer to optimize production processes using Six Sigma and LEAN methods, and to design improvements to equipment and tooling.

The role involves developing experiments, writing protocols, analyzing results, and preparing training and work instructions for production teams. You will coordinate projects, supervise technicians, and ensure compliance with quality and safety guidelines.

Qualifications

• Bachelor’s degree in engineering required.
• 2–4 years of engineering experience required.
• Experience with Six Sigma and LEAN methods preferred.
• Knowledge of FDA regulations for medical devices preferred.
• Experience with manufacturing equipment and documentation.

Responsibilities

• Optimize manufacturing processes using Six Sigma and LEAN methods.
• Develop moderately complex experiments and tests to qualify and validate processes.
• Analyze and resolve CAPA, non-conformances, audit observations.
• Develop training and work instructions for production.
• Establish project plans and use project management tools.
• Oversee manufacturing support tasks and coordinate technicians.
• Perform other duties as assigned by Leadership.

Skills

MS Office Suite

MS Project

Statistical methods

Communication skills

Team collaboration

Problem solving

Manufacturing processes

Quality systems

FDA regulations knowledge

Attention to detail

Education

Bachelor's degree in engineering

Tools

CAD

Job description

Target PR Range: 33-43/hr DOE

Summary

The main function of a manufacturing engineer is to apply knowledge of technical principles and systems/procedures to optimize manufacturing processes.

Job Responsibilities

• Optimize manufacturing processes, including using engineering methods (e.g., SIX Sigma and LEAN methods) for continuous process improvement and/or re-design/design of equipment, tools, fixtures, etc. to improve manufacturing processes, employing technical design skills
• Develop moderately complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports
• Analyze and resolve moderately complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations)
• Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes
• Establish project plans to ensure deliverables are completed to customers expectations, using project management tools (e.g., Project Plan, Risk Analysis, etc.)
• Oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work
• Other incidental duties assigned by Leadership

Skills

• Good computer skills in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)
• Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
• Basic understanding of statistical techniques
• Previous experience working with lab/industrial equipment required (if applicable)
• Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Solid problem-solving, organizational, analytical and critical thinking skills
• Solid understanding of processes and equipment used in assigned work
• Knowledge of and adherence to Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Knowledge of applicable FDA regulations for medical device industry
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment, including the ability to manage vendors and project stakeholders
• Ability to build productive internal/external working relationships
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Education/Experience

• Bachelor’s degree in engineering required.
• 2-4 years experience required.