Senior Design Assurance Engineer

The Interventional Urology Senior Design Assurance Engineer is responsible for supporting new product development and commercial products.

Major Areas of Accountability

• Participate in New Product Development Phase Reviews; lead/participate in Design Reviews.
• Partner with R&D to determine and define design inputs, design outputs, and design input/output relationships.
• Ensure relevant design standards are appropriately applied and satisfied. Create and support the development and validation of new test methods.
• Determine and document risks (Hazard Analysis, DFMEA, PFMEA, UFMEA).
• Support the execution of design verification and validation, as well as usability.
• Generate/support test protocols, manage test execution, investigate test issues, analyze data, and create reports for design verification and validation testing, including shelf life and stability.
• Drive improvement of Design Assurance specific quality system deliverables and processes to increase effectivity and efficiency.
• Support regulatory approvals and responses to regulatory questions.
• Manage the stability test program
• Support and execute design and process changes to commercialized product.
• Support the transfer of new product development projects from development to production.
• Support internal and external audits.
• Manage statistical support for test method validations, sample size requirements, etc.
• Interacts with external contract manufacturers and suppliers
• Provide technical support based on overall project plans with the development of products in compliance with design controls, international standards, and FDA or other regulatory body guidelines.
• Manage product stability program to ensure all products have adequate heat-age and real-time aging for support of shelf life.  
• Conform with Coloplast Code of Conduct and all local Compliance Standards
• Conforms with Coloplast Q/EHS Policy
• Other duties may be assigned.

Basic Qualifications

• BS in Engineering (Biomedical or Mechanical preferred)
• 5+ years related experience and/or training
• ASQ Certified Quality Engineer preferred

Competencies

• Ability to work independently and with general direction.
• Ability to define, organize, and manage individual and team based tasks.
• Provide direction to extended team members.
• Good written and verbal communication, with strong technical writing skills.
• Understanding of design controls, risk management, statistics, test method validation, and new product development processes.
• Knowledge and application of FDA, QSR, ISO 13485 and ISO 14971 requirements.
• Structured and methodical problem-solving approach.
• Ability to travel up to 10%.
• Personifies and fosters the Coloplast Mission, Vision and Values.