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Coloplast Logo Coloplast · IT - Software Development

Senior Design Assurance Engineer, Software

United States, Minneapolis Employment contract 105868.00 - 158802.00 USD / Year · Job Posted May 09, 2026
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Job Description

The Interventional Urology Sr. Design Assurance Engineer, software is responsible for supporting new product development and commercial products. The position is responsible for ensuring all products are structured correctly per standard requirements, quality systems and global regulations. This role will support software project initiatives for active implantable devices and will be a key member of our product development teams.

Job Responsibility

  • Serve as a Design Assurance partner on New Product Development (NPD) projects, participating in and leading phase, design, and test readiness reviews
  • Partner with R&D to define, review, and approve software and system design inputs, outputs, and traceability in compliance with design controls
  • Ensure applicable software, electrical, and system standards are correctly applied
  • support development and validation of software-related test methods
  • Lead and support software risk management activities, including Hazard Analysis, Software FMEA, DFMEA, and usability risk assessments
  • Support planning and execution of software verification and validation (V&V), including protocol development, test execution oversight, issue investigation, data analysis, and reporting
  • Drive continuous improvement of Design Assurance processes, SOPs, and quality deliverables to improve efficiency and compliance
  • Act as Design Assurance support for regulatory submissions, responses, and audits (internal and external)
  • Support design and process changes for commercialized products, including change impact assessment and documentation updates
  • Support design transfer from development to manufacturing, including supplier and contract manufacturer interactions
  • Provide statistical and analytical support for software test methods, validation strategies, and sample size rationale

Requirements

  • Bachelor's Degree in Computer Science, Computer Engineering, Electrical Engineering, or related field
  • 5+ years related experience in this field – Medical device experience preferred
  • Active Implantable medical device system experience
  • Experience with regulatory standards including IEC 62304, 60601, FDA 510(k), ISO 14971, 13485
  • Knowledge of cybersecurity best practices and standards
  • Good written and verbal communication
  • Ability to consistently work, manage and lead with ethical integrity
  • Personifies Coloplast Mission, Values and Vision as well as Coloplast Leadership Promise

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
  • Supportive work environment
  • Team-building activities, volunteer opportunities, and company-sponsored events
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