Process Engineer

Process EngineerThe Process Engineer develops and optimizes robust injection molding processes using scientific molding techniques to support high-quality manufacturing in a regulated medical device environment. This role maintains comprehensive engineering documentation, leads validation and continuous improvement initiatives, and collaborates closely with quality and production teams to ensure stable, compliant, and efficient processes. The Process Engineer also trains and coaches peers and technicians while promoting a safe, clean, and well-organized workplace within a growing, family-owned organization.ResponsibilitiesDevelop robust injection molding processes using scientific molding techniques, including gate freeze analysis, short shot analysis, and related methods.Implement decoupled molding processes to improve consistency, quality, and efficiency in plastic injection molding operations.Maintain complete and accurate engineering files, including Design of Experiments (DOE) reports, process sheets, water diagrams, and other process documentation.Collaborate with the quality team to validate injection molding processes using sound statistical methods and data-driven approaches.Lead and participate in continuous improvement projects focused on process optimization, scrap reduction, cycle time improvement, and overall operational efficiency.Perform failure investigations using structured problem-solving techniques and statistical methods to identify root causes and implement effective corrective and preventive actions.Author test protocols and execute validation protocols, including IQ, OQ, and PQ activities, to meet ISO and FDA medical device regulatory requirements.Verify that all required documents and records are correctly completed and approved prior to process setup and sign-off.Provide training, coaching, and technical guidance to peers and Process Technicians on scientific molding, process control, documentation, and best practices.Maintain and promote a safe and clean working environment by following established housekeeping, organization, and safety practices.Follow all applicable safety procedures and guidelines as outlined in the company safety manual and reinforce safe behaviors on the production floor.Support on-the-floor documentation activities, ensuring that process changes, validations, and production records are properly recorded and controlled.Contribute to the implementation and support of Lean Manufacturing tools, such as 5S and value stream mapping, to improve workflow and reduce waste.Perform other related duties as necessary to support production, quality, and engineering objectives.Essential SkillsHands-on experience in plastic injection molding, including developing and optimizing molding processes.At least 1 year of experience implementing decoupled molding processes and applying scientific molding techniques.Proficiency with scientific molding methods such as gate freeze analysis, short shot analysis, and related analytical techniques.Experience with process validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).Strong process engineering skills with the ability to design, document, and control manufacturing processes in a regulated environment.Ability to conduct and interpret Design of Experiments (DOE) and maintain detailed process documentation such as process sheets and water diagrams.Competence in using statistical methods and data analysis for process validation, failure investigations, and continuous improvement.Experience in leading or supporting continuous improvement initiatives within a manufacturing setting.Ability to author clear, compliant test and validation protocols aligned with ISO and FDA medical device requirements.Strong documentation skills for on-the-floor activities, including process changes, validations, and production records.High school diploma.Secondary education related to plastics injection molding or an equivalent combination of education and hands-on molding experience.Additional Skills & QualificationsBasic familiarity with Lean Manufacturing tools such as 5S and value stream mapping is preferred.Experience working in a medical device manufacturing environment governed by ISO and FDA regulations is highly beneficial.Project management skills to coordinate validation activities, process changes, and continuous improvement projects.Ability to train and coach peers and Process Technicians on process standards, scientific molding techniques, and documentation requirements.Strong problem-solving mindset with the ability to use structured methodologies for root cause analysis and corrective action.Comfort working in a growth-oriented environment where new processes, equipment, and improvements are regularly introduced.Work EnvironmentThis position is fully onsite in a manufacturing facility that focuses on plastic injection molding, including medical device components. The Process Engineer works closely with production, quality, and engineering teams on the shop floor, where scientific molding techniques, validation activities (IQ, OQ, PQ), and process documentation are central to daily operations. The environment emphasizes a safe and clean workplace, with adherence to the company safety manual and established housekeeping and organization standards. The facility culture reflects a family-owned organization experiencing significant growth, with new positions being added to support expanding operations and continuous improvement efforts.Job Type & LocationThis is a Contract to Hire position based out of Saint Paul, MN.Pay and BenefitsThe pay range for this position is $36.00 - $45.00/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 TypeThis is a fully onsite position in Saint Paul, MN.Application DeadlineThis position is anticipated to close on Aug 28, 2026.