Senior Process Engineer

Senior Process EngineerThe Senior Process Engineer develops and optimizes robust injection molding processes using scientific molding techniques, leads continuous improvement initiatives, and ensures compliance with ISO and FDA medical device regulations. This role collaborates closely with quality, manufacturing, and operations teams to validate processes using sound statistical methods, maintain accurate engineering documentation, and drive effective problem-solving and root cause analysis on the production floor.ResponsibilitiesDevelop robust injection molding processes utilizing scientific molding techniques, including gate freeze analysis, short shot analysis, and other decoupled molding methods.Collaborate with the quality team to validate injection molding processes using sound statistical methods and appropriate validation approaches such as IQ, OQ, and PQ.Maintain complete and accurate engineering files, including design of experiments (DOE) reports, process sheets, and water diagrams.Lead continuous improvement projects focused on process optimization, quality enhancement, and operational efficiency in manufacturing engineering.Perform failure investigations using structured problem-solving techniques and statistical analysis to identify root causes and implement effective corrective actions.Author test protocols and execute validation protocols to meet ISO and FDA medical device regulatory requirements.Verify that all documents and process records are correctly completed and approved prior to set-up sign-off on the production floor.Provide training, coaching, and technical guidance to peers and Process Technicians to support skill development and consistent process execution.Maintain and promote a safe and clean working environment, ensuring adherence to established housekeeping and safety practices.Follow all applicable safety procedures and guidelines as outlined in the company safety manual.Support documentation activities on the manufacturing floor to ensure processes are properly recorded, controlled, and updated.Contribute to manufacturing engineering and process improvement initiatives, including the application of Lean Manufacturing concepts where appropriate.Perform other related duties as necessary to support production, quality, and engineering objectives.Essential SkillsExtensive experience with injection molding and plastic injection molding processes, including decoupled molding and scientific molding techniques.7+ years of experience implementing decoupled molding processes and applying scientific molding methods such as gate freeze analysis and short shot analysis.Strong background in manufacturing engineering and process engineering within an injection molding environment.Hands-on experience with process validation activities, including IQ, OQ, and PQ for medical device or regulated manufacturing.Proficiency in using sound statistical methods for process validation, data analysis, and problem-solving.Ability to lead and manage process improvement and continuous improvement projects from concept through implementation.Demonstrated skill in conducting failure investigations, identifying root causes, and implementing corrective and preventive actions.Competence in creating, maintaining, and organizing engineering documentation, including DOE reports, process sheets, water diagrams, and floor documentation.Capability to train, coach, and mentor peers and Process Technicians in process standards and best practices.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 within ISO and FDA medical device regulatory environments is highly advantageous.Background in project management for manufacturing and process improvement initiatives.Strong communication skills to collaborate effectively with quality, operations, and technical teams.Attention to detail and a disciplined approach to documentation, validation, and compliance.Ability to work independently while also contributing to cross-functional teams in a fast-growing organization.Comfort with continuous improvement culture and openness to adopting new methods and technologies.Work EnvironmentThis is an onsite role in a manufacturing environment focused on plastics injection molding and medical device-related production. The Senior Process Engineer works on the production floor and in engineering areas, interacting regularly with quality, operations, and technical staff. The environment emphasizes safety, cleanliness, and adherence to documented procedures, with a strong focus on maintaining a safe and orderly workspace. The company is family owned and currently experiencing significant growth, creating opportunities to contribute to expanding operations and continuous improvement initiatives.Job Type & LocationThis is a Contract to Hire position based out of Saint Paul, MN.Pay and BenefitsThe pay range for this position is $43.00 - $57.00/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 Sep 18, 2026.