Senior Design Assurance Engineer


Minneapolis, MN, US

Job Family:  Quality Assurance
Country/Region:  United States

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



  • 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.




Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 14,000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.


Visit us on

Watch the film. Follow us on LinkedIn. Like us on Facebook.


Coloplast is committed to a policy of Equal Employment Opportunity (EEO) which means we employ and promote individuals based on their merits, regardless of race, color, religion, sex, national origin, age, disability, veteran status, pregnancy, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, status with regards to public assistance or any other protected classification.


Nearest Major Market: Minneapolis