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Senior Design Assurance Engineer

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Coloplast

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Location:
United States , Minneapolis

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Category:
IT - Administration

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Contract Type:
Not provided

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Salary:

105868.00 - 158802.00 USD / Year
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Job Description:

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

Job Responsibility:

  • 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

Requirements:

  • 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
What we offer:
  • Comprehensive medical, dental, and vision insurance plans
  • company sponsored wellness programs and mental health resources
  • paid leave of absence for qualifying events
  • generous paid parental leave for both birthing and non-birthing parents
  • competitive 401(k) plan with company match that vest immediately
  • financial planning services
  • corporate discount programs for goods and services
  • generous paid time off
  • flexible work hours
  • flexible work arrangement options
  • opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement
  • recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events
  • a supportive work environment
  • participate in team-building activities, volunteer opportunities, and company-sponsored events

Additional Information:

Job Posted:
February 01, 2026

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