Process Development Engineer III

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.

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.

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 meets 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 corrects equipment problems or process parameters that produce non-conforming products, low yields, or product quality issues
• Analyze and map processes, assesses efficiency, and implements 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; posses the ability to troubleshoot issues using disciplined root cause analysis tools
• Mechanical 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
• A bility to work in a fast-paced team environment; a bility to prioritize and multitask

Skills

• P preferred
• 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

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