Position:

Manufacturing Engineer II, Req#: 18917-1

Location:

Naperville, IL (100% Onsite)

Duration:

12+ Months Contract with a high possibility of extension

The main function of a manufacturing engineer is to apply knowledge of technical principles and the client's systems/procedures to optimize manufacturing processes. We are seeking a Senior Manufacturing Engineer to lead equipment qualification and validation activities for a custom-built processing system (TTU) operating in a clean room environment. This role is ideal for a hands-on engineer with deep

IQ/OQ/PQ

experience in regulated manufacturing who can plan, coordinate with vendors, and execute validation protocols with precision.

Education and Experience:

Bachelor's degree in engineering (Mechanical, Chemical, Manufacturing, or related field)

2-4 years of experience required.

Previous experience with medical devices is ideal.

Strong hands-on experience with equipment validation — specifically

IQ/OQ/PQ

protocols

Background in regulated manufacturing environments (medical devices, pharmaceuticals, or similar)

Experience working in or supporting clean room environments

Demonstrated ability to create detailed plans and execute them methodically

Familiarity with intrinsically safe/hazardous area classifications and the ability to set appropriate user requirements for flammable or explosive chemical environments

Additional 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 the client's Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing

Knowledge of applicable FDA regulations for the 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 the environment and prevention of pollution under their span of influence/control

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 the customer's 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

Lead installation, operational, and performance qualification (IQ/OQ/PQ) activities for the TTU — a custom rotational oven system used in clean room manufacturing

Validate rotational speed parameters and ensure proper protocol execution on the equipment

Define user requirements for equipment operating in intrinsically safe environments involving flammable and explosive chemicals

Collaborate with outside vendors on equipment design work, reviewing designs for technical completeness and identifying gaps

Develop validation plans and execute against them with strong attention to detail and schedule adherence

Support commissioning and qualification of clean rooms and processing equipment

Partner with cross-functional teams and project stakeholders to deliver qualification milestones on time

Why TalentBurst?

At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.

Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships.

We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.

TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.