Senior Injection Molding Tooling Engineer

Actalent; Minnesota; On-site; USD 66,000 - 87,000; Full time

Job summary

Actalent in Saint Paul, MN is seeking a Tooling Engineer to develop and optimize injection molding processes using scientific molding techniques. You will lead continuous improvement, perform DOE and validations, and ensure ISO and FDA compliance while collaborating with quality and process teams.

This onsite contract role requires hands-on experience with molding machine setup, process debugging, and coaching technicians on best practices.

Qualifications

• 3+ years hands-on experience with injection molding processes.
• 3+ years experience with IQ, OQ, and PQ validation activities in a regulated environment.
• 3+ years experience with validations and documentation, including authoring and executing protocols.

Responsibilities

• Develop and optimize robust injection molding processes using scientific molding techniques.
• Maintain engineering files including DOE reports and process sheets.
• Collaborate with quality to validate processes using statistical methods and validation protocols.
• Lead continuous improvement projects to improve process efficiency and quality.
• Perform failure investigations to identify root causes and implement corrective actions.
• Author and execute validation protocols to comply with ISO and FDA requirements (IQ/OQ/PQ).
• Ensure documents are correctly completed and approved prior to process sign-off.
• Provide training and coaching to peers and technicians on molding processes and troubleshooting.

Skills

Injection molding

IQ/OQ/PQ validation

Documentation & DOE

Statistical methods

Continuous improvement

Lean/Six Sigma

Regulatory compliance ISO/FDA

Training mentoring

Job description

Actalent in Saint Paul, MN is seeking a Tooling Engineer to develop and optimize injection molding processes using scientific molding techniques. You will lead continuous improvement, perform DOE and validations, and ensure ISO and FDA compliance while collaborating with quality and process teams.

This onsite contract role requires hands-on experience with molding machine setup, process debugging, and coaching technicians on best practices.