Process Development Engineer III

Cretex Medical Component and Device Technologies; West View Terrace (MN); On-site; USD 90,800 - 136,200; Full time

Benefits offered by this job

401k with company match

Onsite health clinics

Paid time off

Job summary

Cretex Medical Component and Device Technologies is seeking a Process Development Engineer III to develop and optimize advanced manufacturing processes in West View Terrace, Minnesota. The ideal candidate will be responsible for transforming customer designs into scalable production processes while collaborating with cross-functional teams.

Responsibilities include designing manufacturing processes, troubleshooting issues, analyzing data, and mentoring junior engineers. The position requires a Bachelor’s degree in Engineering and 5 years of relevant experience, offering a competitive salary and comprehensive benefits.

Qualifications

• 5 years of engineering experience in a related manufacturing environment.
• Demonstrated ability to develop and deploy new processes.
• Experience in an ISO13485/GMP environment.

Responsibilities

• Specify, design, and implement manufacturing processes that meet quality and cost requirements.
• Analyze data to ensure processes meet expectations.
• Collaborate with quality engineers to develop measurement systems.

Skills

Problem-solving skills

Manufacturing process design

Lean manufacturing experience

Project management experience

Microsoft Office proficiency

Education

Bachelor's Degree in Mechanical, Industrial, or related field

Tools

3D CAD software (e.g. Solidworks)

Statistical software

Job description

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 www.cretexmedical.com.

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 correct equipment problems or process parameters that produce non-conforming products, low yields, or product quality issues
• Analyze and map processes, assess efficiency, and implement 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; possess 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
• Excellent communication, leadership and influencing skills; clear and effective verbal and written communication skills
• High level of energy, personal accountability, and integrity
• Highly detail oriented; checks own work, keeps accurate records, organizes information effectively
• Ability to tolerate ambiguity, multiple priorities, and short deadlines
• Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher)
• Attention to detail and organization skills
• Ability to work in a fast-paced team environment; ability to prioritize and multitask

Preferred Knowledge, Skills and Abilities

• Continuing Education; including participation in local chapters, associations, and/or organizations
• Proficiency in 3D CAD software (i.e. Solidworks, etc.), Miniab or SPC within Excel
• Understanding of GD&T
• Experience in an ISO13485/GMP environment
• Engineering experience with medical devices

What is it like to work at Cretex Medical?

We recognize the contribution of every individual and promote growth, safety and security for all our employees. Cretex Medical values performance and pays competitive wages along with a rich benefit package. We offer a positive work environment with a focus on continuous improvement.

Here are some of things that employees have said about working for Cretex Medical:

• “The culture at Cretex is collaborative. Everyone here is willing to help you whether it is a director, a machinist, or your boss. Everyone is always willing to help you figure out a project and get it done right.”
• “I would tell potential interns that Cretex is a great company to work for. It has set a high bar for corporate culture as well as the quality of work you can do. I would definitely recommend it.”
• “I learned that I really like the medical device industry. The importance and the gravity of what we do here is felt by the employees. You can have that passion in your work because you know what you are striving for is to save lives.”

Pay Range

USD $90,800.00 - USD $136,200.00 /Yr.

Pay Range Details

This pay range reflects the base hourly rate or annual salary for positions within this job grade, based on our market-based pay structures. Actual compensation will depend on factors such as skills, relevant experience, education, internal equity, business needs, and local market conditions. While the full hiring range is shared for transparency, offers are rarely made at the minimum or maximum of the range.

Company Benefits

All Employees:

Our 401k retirement savings plan with a company match contribution; onsite health clinics, discretionary holiday bonus program (based on years of service), Cretex University, 24/7 employee assistance program with access to five confidential visits with a licensed counselor at no cost, wellness program with incentives, an employee death benefit, and employee sick and safe leave are available to all Cretex employees.

20+hours:

Cretex’s medical benefit package includes: comprehensive medical insurance with access to virtual providers; dental insurance (Little Partners Dental benefit covers services 100 percent for children 12 and younger when seen by a Health Partners in network provider); vision insurance; a pre-tax health savings account, healthcare and dependent care pre-tax reimbursement accounts; paid holidays, paid time off; and our discretionary profit sharing program are available to employees working 20+ hours/week.

30+ hours:

Parental Leave, accident and critical illness benefits, optional employee, spouse, and child life; short and long term disability; company provided life insurance; and tuition assistance programs are available to employees working 30+ hours per week.

(Some benefits are subject to eligibility criteria.)

Applicants will receive consideration for employment regardless of their race, color, creed, religion, national origin, sex, sexual orientation, gender identity, disability, age, veteran status, marital status, family status, status with regard to public assistance, or any other protected status as required by law.

Our company uses E-Verify to confirm the employment and eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.