Process Engineer

About the role

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.

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

Qualifications

• 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
• Ability to troubleshoot issues using disciplined root cause analysis tools
• 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

Skills

• P referred
• 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.

Company Benefits

• All Employees: 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
• 20+hours: 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
• 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

Pay Range

USD $75,000.00 - USD $112,600.00 /Yr.