Quality Engineer - New Product Development at Cretex Medical Component and Device Technologies in Brooklyn Park, Minnesota

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.



The Quality Engineer



Provides quality assurance support for the New Product Development (NPD) department, participating in product requirement definition, concept development, rapid prototyping, and Design for Manufacturability and Inspection (DFM/DFI) activities. They are responsible for defining, implementing, and improving quality-related practices and procedures. Additionally, they develop inspection methods, perform inspections in support of prototype verification, and serve as the primary quality interface between NPD and New Product Introduction (NPI) to ensure smooth transitions from development to production.



Responsibilities

• Provide quick-turn Quality Engineering support, including DFM/DFI guidance and inspection support for new product development projects.
• Operate and program inspection equipment, such as Micro-Vu (InSpec), OGP (MeasureMind 3D), and CMM (PC-DMIS), to verify product quality.
• Develop, implement, and refine inspection methods and measurement techniques to support prototype verification and early-stage product development.
• Aid in the development of inspection and control plans as part of the risk management process.
• Analyze measurement data to identify trends, root causes of quality issues, and opportunities for improvement.
• Act as the primary quality interface and bridge between NPD and NPI, ensuring effective transfer of quality knowledge and processes.
• Support manufacturing process development and characterization activities, including measurement system analysis (MSA), gage R&R, and capability studies (Cp, Cpk).
• Monitors the utilization of employee safety and OE programs
• Partners with the other business segments: sales/marketing, customer service, engineering, quality, and finance
• Understands customer needs and the core business markets we serve
• Ensures business systems are implemented, maintained, and functioning properly
• Participates in required company meetings
• Maintains an organized work area (5S)
• Participates in the Operational Excellence Program
• Supports and complies with the company's Quality System, ISO, and medical device requirements
• Completes all other work duties as assigned

Qualifications

• Bachelor's Degree: Mechanical, Industrial, or other Engineering or Physical science.
• 1+ years of experience in engineering in a machining or manufacturing setting
• Willingness to work hands-on with prototypes and production components.
• Knowledge of Gage R&R, capability studies, and statistical sampling plans
• Knowledge of statistical tools such as Minitab and SPC for Excel
• Knowledge of quality systems (ISO 13485), regulatory requirements (cGMP, 21 CFR 820) and industry standards
• Proficiency in blueprint reading and GD&T to translate into inspection requirements.
• Excellent communication and influencing skills
• High level of energy, personal accountability, and integrity
• Highly detail oriented; checks own work, keeps accurate records, organizes information effectively

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."

We encourage you to explore the many opportunities Cretex Medical can offer you as a valued team member.

Pay Range

USD $66,900.00 - USD $92,000.00 /Yr.Company Benefits




Pay Range Details:



Quality Engineer I: $66,900-$83,600


Quality Engineer II: $73,600-$92,000



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. Apply Now