Process Engineer

Trelleborg Medical Solutions

📍Delano, MN
Posted May 20, 2026

Job Overview

Position

Process Engineer

Company

Trelleborg Medical Solutions

Location

Delano, MN

Work Type

On-site

Job ID

li-4406568357

Job Description

Sista ansökningsdag
2026-07-29
Plats:
USA - Delano, MN

The Process Engineer follows good manufacturing practices (GMP) and principles to develop robust manufacturing processes. Has a primary role in the engineering of new or modified manufacturing operations in a clean-room environment.

Salary band $79,500-102,000

Tasks and Responsibilities

  • Analyzes new product specifications and translates these into manufacturing processes to establish production rates, achieve expected quality levels and establish reliability of finished product.

  • Expert user of manufacturing equipment, intimately understands machine functions and can determine what equipment is required to produce a given product

  • Working knowledge of automation systems to be able to use and troubleshoot them once implemented by the automation team

  • Conducts reviews of new and revised tooling.

  • Acts as tooling design review input champion.

  • Develops and optimizes process parameters for new tools.

  • Develops process parameters for secondary operations such as ultrasonic welding, bonding, cutting, slitting, and testing.

  • Conducts data analysis and collaboration with Quality Engineering.

  • Understands process validation steps and goals and works with the quality engineering team to provide guidance on how to validate new production processes

  • Identifies Operational Qualification (OQ) process parameters and Performance Qualification (PQ) settings.

  • Develops and documents standard operating procedures and product-specific operating procedures

  • Trains manufacturing personnel on new production processes

  • Performs DOEs, and participates in the development of control plans, Process Maps, and PFMEA documentation.

  • Organizes internal cross-functional teams and corresponding outside vendors needed to meet project needs.

  • Uses standard problem solving tools, e.g., 8D, 5 Whys, Fishbone.

  • Applies effective inter-departmental communication and escalation.

  • Owns tooling and process from a manufacturability standpoint from development to production release.

  • Partners with Quality department on investigation and corrective action for any failed First Article Inspection or OQ/PQ.

  • Leads internal projects to investigate equipment or process related items

  • Understands basic material chemistry

  • Understands test methods used to inspect the products being produced

  • Works directly with customers to discuss topics such as design for manufacturing and material selection

Education and Experience

Required

  • Bachelor's degree in Industrial, Manufacturing, Plastics or Mechanical Engineering or related discipline or 10 years equivalent work experience.

Desired

  • Hands-on (operating manufacturing equipment) processing experience with injection molding and elastomer extrusion

Competencies

  • Ability to read, write and speak the English language.

  • Ability to communicate clearly by conveying and receiving ideas, information and direction effectively

  • Ability to demonstrate adequate job knowledge to deliver a world class performance

  • Ability to challenge oneself to consistently meet all goals and deadlines

  • Willingness to strive for excellence by producing work that is free of errors and mistakes

  • Desire to delight both customers and coworkers by offering encouragement, fostering teamwork and addressing conflict appropriately

  • Commitment to making improvements company wide

  • Demonstrated competence using Microsoft Office

  • Use of statistical analysis software

  • Use of 3D modeling software such as SolidWorks

  • Interpersonal skills and good communication technique

  • Ability to coordinate multiple projects and deadlines, manage and identify scope

  • Act as a project leader on major projects

  • Lean Manufacturing - proficient in use of problem solving tools such as 5-Why, Fishbone, 8D etc

  • Understanding of manufacturing processes for medical components and devices

  • Good understanding of metrology principles and methods

#TMS

Apply here!

Interview Prep

AI-powered insights to help you prepare

Key Skills

Required:
Preferred:

Practice Questions

💡Technical Questions (3)
  • 1.Can you walk me through your approach to identifying Operational Qualification (OQ) parameters and Performance Qualification (PQ) settings for a new manufacturing process?
  • 2.How do you utilize Design of Experiments (DOE) when developing and optimizing process parameters for new tooling in a medical manufacturing environment?
  • 3.Describe your experience working with secondary operations such as ultrasonic welding or bonding, and how you ensure these processes meet strict quality standards.
🎯Behavioral Questions (3)
  • 1.Tell me about a time you had to investigate a failed First Article Inspection or OQ/PQ run. How did you partner with the Quality department to resolve it?
  • 2.Give an example of a time you acted as the tooling design review champion. How did you ensure manufacturability was prioritized from development to production release?
  • 3.Describe a situation where you had to train manufacturing personnel on a new production process you developed. How did you ensure they understood and followed the new SOPs?
🧩Situational Questions (2)
  • 1.You are working directly with a customer to discuss design for manufacturing and material selection, and they propose a design that will be extremely difficult and costly to mold. How do you handle this conversation?
  • 2.An automation system recently implemented by the automation team goes down during a critical production run, and you are asked to troubleshoot it. You have a working knowledge but are not the automation expert. What is your approach?

Resume Keywords

Make sure these keywords appear on your resume

Process ValidationOQ/PQDesign of ExperimentsDOEPFMEAInjection MoldingClean-roomGMPTooling Design8D Problem SolvingUltrasonic WeldingSolidWorks

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