Tooling Engineer

Actalent; Saint Paul (MN); On-site; USD 66,000 - 87,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) plan

Life insurance

Disability insurance

HSA

Transit benefits

PTO / Vacation

Job summary

Actalent in Saint Paul, MN is seeking a Tooling Engineer to develop and optimize injection molding processes in a strictly regulated, on-site setting. You will lead DOE initiatives, validate processes, and ensure GMP/ISO compliance while collaborating with quality and production teams.

This contract role emphasizes continuous improvement, robust documentation, and hands-on mentoring of technicians on molding equipment, process setup, and troubleshooting in a fast-paced manufacturing environment.

Qualifications

• Minimum 3 years hands-on injection molding experience.
• Experience with IQ, OQ, PQ in regulated environments.
• Strong documentation and protocol authoring ability.

Responsibilities

• Develop and optimize robust injection molding processes using scientific molding techniques.
• Maintain engineering files and DOE reports.
• Lead continuous improvement projects for quality and efficiency.
• Perform failure investigations and root-cause analyses.
• Validate processes per ISO and FDA requirements.

Skills

Injection molding

IQ/OQ/PQ validation

Documentation & protocols

Statistical methods

Process improvement

Lean Six Sigma

Mold tooling knowledge

Troubleshooting

Tools

DOE (Design of Experiments)

Statistical analysis tools

Job description

Job Title: Tooling Engineer

Job Description

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.

Responsibilities

• 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.

Essential Skills

• 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.

Additional Skills & Qualifications

• 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.

Work Environment

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.

Job Type & Location

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

Pay And Benefits

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

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job‑related factors.

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 benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)
• Workplace Type This is a fully onsite position in Saint Paul,MN.
• Application Deadline This position is anticipated to close on Oct 2, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.