The Tooling Engineer develops and optimizes robust injection molding processes using scientific molding techniques and sound statistical methods. This role leads continuous improvement initiatives, conducts failure investigations, and ensures all molding processes and documentation meet ISO and FDA medical device regulatory requirements. The Tooling Engineer collaborates closely with quality and process teams, provides training and coaching, and promotes a safe, clean, and compliant work environment.

• Develop and optimize robust injection molding processes using scientific molding techniques, including gate freeze analysis, short shot analysis, and other relevant methodologies.
• Maintain comprehensive engineering files, including Design of Experiments (DOE) reports, process sheets, and water diagrams, ensuring documentation is accurate and up to date.
• Collaborate with the quality team to validate injection molding processes using sound statistical methods and established validation protocols.
• Lead continuous improvement projects focused on process efficiency, product quality, and operational effectiveness.
• Perform failure investigations using structured problem-solving techniques and statistical methods to identify root causes and implement effective corrective actions.
• Author test protocols and execute validation protocols to comply with ISO standards and FDA medical device regulatory requirements, including IQ, OQ, and PQ.
• Verify that all documents are correctly completed and approved prior to process set-up sign-off.
• Provide training, coaching, and technical guidance to peers and Process Technicians on molding processes, troubleshooting, and best practices.
• Maintain and promote a safe, clean, and organized working environment in accordance with company policies.
• Follow all applicable safety procedures and guidelines as outlined in the company safety manual.
• Perform other related duties as necessary to support production, quality, and engineering objectives.

• Minimum 3 years of hands-on experience with injection molding processes.
• Minimum 3 years of experience with IQ, OQ, and PQ validation activities in a regulated environment.
• Minimum 3 years of experience with validations and documentation, including authoring and executing protocols.
• Strong knowledge of plastics injection molding and tooling, including molding machine setup and optimization.
• Proficiency in scientific molding techniques such as gate freeze analysis and short shot analysis.
• Experience with troubleshooting and process engineering in a manufacturing setting.
• Demonstrated ability to lead continuous improvement initiatives.
• Working knowledge of lean manufacturing and Six Sigma principles.
• Ability to apply statistical methods to process validation and failure investigations.
• Strong attention to detail and commitment to accurate, compliant documentation.

• Experience working with medical device manufacturing processes subject to ISO and FDA regulations.
• Familiarity with DOE (Design of Experiments) methodology for process development and optimization.
• Ability to collaborate effectively with quality, engineering, and production teams.
• Strong problem-solving skills with a structured, data-driven approach.
• Comfortable providing training, coaching, and technical support to technicians and peers.
• Continuous improvement mindset with a focus on safety, quality, and efficiency.
• Experience in a family-owned or closely held manufacturing environment is a plus.

This is an onsite role in a manufacturing environment focused on plastics injection molding and tooling. The Tooling Engineer works directly with molding machines and related equipment, collaborating with quality, process, and production teams on the shop floor and in engineering offices. The environment emphasizes safety, cleanliness, and adherence to documented procedures and regulatory requirements. Work follows established safety guidelines as outlined in the company safety manual, with a strong focus on maintaining an organized and compliant workspace.

This is a Contract position based out of Saint Paul, MN.

The pay range for this position is $48.00 - $63.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the