Process Development Engineer III

Location: Dassel

Overview

About Cretex Medical

Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. Our customers view us as a trusted partner in the areas of injection molding, laser processing, metal stamping and device assembly. Learn more at

Position Summary

The Process Development Engineer III is a key technical leader responsible for developing, optimizing, and implementing advanced manufacturing processes. This role acts as the vital bridge between concept and reality, transforming complex customer designs into robust, repeatable, and scalable production processes that meet demanding quality, productivity, and cost requirements.

In this position, you will own the development, scale-up, and continuous improvement of core manufacturing methodologies. Utilizing strong engineering fundamentals and data-driven problem solving, you will establish critical process parameters, spearhead validation activities, troubleshoot complex production issues, and continuously enhance manufacturing capability.

The ideal candidate is a technically curious, results-driven engineer who thrives on solving complex technical challenges and driving operational excellence. This position offers the opportunity to collaborate directly with cross-functional teams and customers, spearhead cutting-edge manufacturing solutions, and play a direct role in bringing innovative, high-impact processes to life.

Responsibilities

* Specify, design, characterize, optimize and implement manufacturing processes (including equipment) that can meet design, quality, productivity, and cost requirements

* Utilize engineering principles to investigate and troubleshoot process issues, determine causes, and implement solutions

* Analyze data to ensure process meeting expectations (ANOVA, DOEs, Tolerance Stackups, SPC, etc.)

* Generate documentation of the processes (i.e. engineering reports, Processes FMEAs, characterization studies, qualification protocols, etc.)

* Develop and implement work instructions to complement the processes developed

* Establish project timelines, track progress, manage to the schedule and communicate project status to management and other stakeholders

* Collaborate with quality and measurement engineers to develop needed measurement and quality systems

* Collaborate with customer teams as required to provide DFM for their designs and integration of requirements into internal processes

* Provide technical coaching and feedback to the technical teams and production employees

* Analyze and solve problems from basic engineering principles, theories, and concepts through to a wide range of complex and advanced problems which require novel and innovative approaches or a breakthrough technology

* Monitor performance of equipment, machines, and tools and corrects equipment problems or process parameters that produce non-conforming products, low yields, or product quality issues

* Analyze and map processes, assesses efficiency, and implements complex project activities

* Mentor Engineer I and II

* Support and comply with the company Quality System, ISO, and medical device requirements

* Read, understand, and follow work instructions and standard work

* Partner with other business segments: sales/marketing, customer service, engineering, quality, and finance

* Understand customer needs and the core business markets we serve

Qualifications

* Bachelor's Degree in Mechanical, Industrial, or other Engineering Science or related field

* 5 years of engineering experience in a related manufacturing environment; including state of the art manufacturing technology/concepts and cost reductions

* Demonstrated ability to develop and deploy new processes

* Strong problem solving skills; posses the ability to troubleshoot issues using disciplined root cause analysis tools

* Manufacturing process design and validation

* Lean manufacturing experience

* Team dynamic skills (communication, accountability, decision-making, feedback, meeting management, managing conflict)

* DOE, SPC, FMEA, GMP, QSR

* Knowledge of statistical software; knowledge of materials and related processes

* Project management experience

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