Sr. Design Engineer - NPI
Cretex Medical Component and Device Technologies

Job Info

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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.

Sr. Design Engineer Position Summary:

The Sr. Design Engineer will support New Product Introduction (NPI) activities up through the hand-off to production. Up-front engineering includes CAD modeling, Design for Manufacture (DFM) review and customer interaction, mold filling analysis, concept development, Statement of Work (SOW) and estimating, equipment and mold scoping, and quoting with vendors. This role will serves on the cross-functional new product engineering team and is responsible for mold design reviews and managing the vendors, ensuring that mold tooling is appropriately specified and constructed to meet all requirements and complies with company standards. Ongoing support through grooming and process development is also an essential function of this role.
Responsibilities

Sr. Design Engineer Responsibilities:

• DFM review of customer-owned designs, ability to guide design process to ensure manufacurability
• Develop concepts for the process(es) to manufacture medical devices and components
• Perform Mechanical design/redesign of medical device products applying industry standards (e.g. ASME Y14.5M-1994) to detail drawings
• Follow standard design development process using design controls, ECOs, ECRs, DCOs, revision controls, etc
• Use statistical analysis techniques and tools such as Minitab to analyze data for making critical decisions impacting manufacturing development
• Computer-aided design (CAD) modeling of medical components and devices, tooling, and fixtures using SolidWorks and/or Pro-E Creo CAD software
• Interpret control drawings, redline review of drawings, and create 2D drawings for components/tools/fixtures
• Perform risk management activities - analysis, assessment, and mitigation - ensuring successful launch into production
• Support new business development by providing concepts, process flows, cost estimations, manufacturing strategies, Statements of Work (SOWs), and preparing bid proposals
• Detailed mold filling and predictive analysis using Moldex 3D or other CFD software
• Collaborate on and create documentation such as Design Failure Modes and Effects Analysis (dFMEA)
• Specify, design, and procure mold tooling, fixtures, and equipment needed for the manufacture of customers' products
• Ensure the designs for tooling and equipment follow industry best practices and will meet company standards and product requirements
• Prepare for and conduct engineering design reviews with customers for their components; review tooling and equipment designs with vendors and the internal stake holders
• Develop assembly and test procedures, process flowcharts, testing plans, and TMV reports
• Design engineering experiments and coordinate execution of design verification activities
• Troubleshoot and debug failure modes during the development cycle
• Familiar with statistical quality processes such as gage repeatability and reproducibility (GR&R) and capability studies
• Collect data, analyze, and make well-informed data-driven decisions
• Continuous improvement of specifications, test methods, designs, materials, and/or processes
• Create. Modify, and maintain documentation using CAD/PLM software
• Comprehensive knowledge of FDA IQ/OQ/PQ validation process required to support those activities throughout the development cycle
• Contributing member of the cross-functional engineering team working to meet project goals and objectives
• May train and/or provide work direction to engineering support personnel, interns, co-ops, consultants, etc.
• Maintain CAD software and hardware, materials, records, and resources
• Maintain print and document control systems
• Ability to work in a manufacturing environment

Qualifications

Sr. Design Engineer Requirements:

• Degree in Mechanical Engineering or relevant experience in a design function
• 10 years of experience in a Design Engineering or Tooling Engineering role or equivalent
• Blueprint reading, GD&T, SPC
• Proficient in 3D Computer-Aided Design (CAD), preferably Solidworks and/or Creo (Pro-E)
• Experience working independently under pressure with multiple deadlines
• Ability to consistently achieve short and long-term business results
• Ability to follow through on commitments and holds team members accountable

Sr. Design Engineer Preferred Requirements:

• Injection molding part design and tooling experience
• Knowledge/experience in Scientific Molding Process development theory and techniques
• Design simulation experience (FEA, Moldex 3D, Autodesk Moldflow, etc.)
• Experience with complex medical device design and manufacturing
• Prior experience sourcing and managing tooling and equipment builds

Physical & Environmental Demands:

Cretex Companies use cutting oils, solvents, and other chemicals in the manufacturing process. Testing is conducted on a periodic basis to ensure that all chemicals are kept well below the OSHA permissible exposure levels.

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.

Company Benefits:

Cretex Medical offers a full benefit package to its employees. Benefits include medical, dental, vision and life insurance options. Cretex Medical also offers a 401(k)-retirement plan with employer match, profit sharing, short- and long-term disability insurance, paid time off and holiday pay.

Cretex Medical also offers company-specific benefits, such as:

• Employee Appreciation events
• Volunteer Opportunities
• Training and Development opportunities
• Tuition Reimbursement
• New state-of-the-art facility in Brooklyn Park!

Applicants will receive consideration for employment regardless of their race, color, creed, religion, national origin, sex, sexual orientation, 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.

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