Process Development Engineer

The Interventional Urology Process Development Engineer is responsible for supporting new and existing product and process development throughout the development lifecycle.

Major Areas of Accountability:

• Interpret engineering drawings and specifications.
• Assess product & process risks.
• Provide statistical inputs to test method validations, sample size requirements, etc.
• Partner with Sourcing and Supplier Quality on evaluation and selection of contract manufacturers & suppliers
• Familiar with different device-build processes such as injection molding, transfer molding, dip molding, soldering, crimping, laser welding, adhesives, & ultrasonic welding.
• Develop device-build processes through screening & range finding studies, then using DOEs to establish process windows.
• Validate processes by correctly installing equipment (IQ) to operate per requirement (OQ) and safely perform (PQ).
• Transfer equipment & processes to manufacturing, and train line operators.
• Responsible for design history file inputs
• Create device master records
• Support cross-functional VOC studies.
• Obtain and maintain all necessary information and experimental test results related to assigned projects by various means of recording
• Develop product in compliance with design controls, international standards, and FDA or other regulatory body guidance
• Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies.
• Other duties as assigned

Basic Qualifications:

• Bachelor's Degree in engineering, Mechanical preferred
• +2 years related experience
• DOE and GR&R experience
• Good understanding of engineering concepts and principles
• Familiarity with statistical analysis (e.g., two-sample t-test, tolerance limit calculation)
• Familiarity with process failure mode analysis (pFMEA, Fault Tree Analysis), hazard analysis and other risk management procedures
• Good understanding of Quality Management Systems and standard operating procedures
• Ability to travel up to 10%

Knowledge, Skills and Abilities:

• Ability to work independently or collaboratively
• Ability to take verbal instructions and translate them into goals and objectives
• Good written and verbal communication
• Pro-active; high-performer and results oriented
• Perform with ethical integrity
• Personifies Coloplast Mission, Values and Vision as well as Coloplast Leadership Principals