Process Engineer

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 Engineer will be responsible for the development and execution of select technical operations including the establishment of process parameters, support of validation activities, and troubleshooting production issues in a manufacturing facility. This position will also provide direction and support for existing products including support to the Manufacturing organization to facilitate efficient operations within the production area, to optimize existing processes and to ensure that production goals are met.

Responsibilities

• Utilize engineering principles to establish capable processes for new and existing tooling including the use of modeling tools
• Serve as a Subject Matter Expert (SME) for catheter assembly processes
• Support adjacent catheter manufacturing technologies such as braiding, coil winding, polymer reflow, and catheter tipping
• Standardize and support set-up procedures and standard tools to continuously reduce set-up times
• Work with cross functional teams to support production transfers
• Develop, model and document processes that demonstrate the achievement of functional, financial, and quality goals
• Participate in the development of validation protocols in cooperation with Quality, Sales, and Operations functions
• Execute comprehensive OQ protocols that clearly define, demonstrate, and document process windows sufficient to achieve Process Capabilities that meet or exceed Customer’s and/or Cretex Process Capability requirements on critical to quality features
• Support the Quality team while they execute comprehensive PQ protocols that clearly define, demonstrate, and document process windows sufficient to achieve Process Capabilities that meet or exceed Customer’s and/or Cretex Process Capability requirements on critical to quality features
• Identify and support continuous improvement opportunities for processes that are performing below Cretex quality standards
• In collaboration with Quality, analyze weekly yield and inspection data to identify and resolve problem processes and tools
• In collaboration with Operations, analyze weekly delivery and productivity data to identify and resolve problem processes and tools
• Provide technical coaching and feedback to production employees and the support team
• Communicate with customers as necessary regarding technical details of individual assembly processes and validation process
• Partner with the other business segments sales/marketing, customer service, engineering, quality, and finance
• Understand customer needs and the core business markets we serve
• Ensure business systems are implemented, maintained, and functioning properly
• Support and comply with the company Quality System, ISO, and medical device requirements
• Read, understand, and follow work instructions and standard work
• Maintain an organized work area (5S)
• Participate in required company meetings
• Complete all other work duties as assigned

Requirements

• Ability to work in a manufacturing environment
• Bachelor’s degree in Engineering or related field, or equivalent training and experience
• 3-5 years of experience in a related manufacturing environment
• Catheter assembly experience
• Ability to read and understand quality plans
• Must possess the ability to troubleshoot issues using disciplined root cause analysis tools
• Understanding of a variety of Catheter assembly processes and secondary operations equipment
• Depth of knowledge in material and material grades for polymer reflow, sizing and its interactions during assembly
• Strong Leadership skills
• Able to consistently achieve short- and long-term business results
• Able to follow through on commitments and holds team members accountable
• Strong problem-solving skills
• Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher)
• Clear and effective verbal and written communication skills
• Attention to detail
• Organizational 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
• Experience with medical catheter manufacturing and Hydrophilic coating
• Team dynamic skills (communication, accountability, decision-making, feedback, meeting management, managing conflict)

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 and Benefits

Pay Range: USD $75,000.00 - USD $112,600.00 /Yr.

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.

Benefits:

• 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
• Employee sick and safe leave

• For employees working 20+ hours/week:
• 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
• Discretionary profit sharing program

• For employees working 30+ hours per week:
• Parental Leave, accident and critical illness benefits, optional employee, spouse, and child life
• Short and long term disability
• Company provided life insurance
• Tuition assistance programs

(Some benefits are subject to eligibility criteria.)

Equal Opportunity Employer: 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.