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R&D Engineer, Product Support

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Coloplast

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Location:
United States , Minneapolis

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

90745.00 - 136118.00 USD / Year
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Job Description:

A Product Support, R&D Engineer will be responsible for performing a variety sustaining design tasks over a broad range of products in Interventional Urology. Contribute to fulfilling business goals of Coloplast for new products, current products and line extensions. This position will include laboratory work, interacting with internal Coloplast personnel, suppliers and external physicians or HCPs.

Job Responsibility:

  • Provide technical support based on project plans with both new development products and commercialized products
  • Complete relevant tasks to fulfill major milestones, identifying processing parameters, materials, equipment and requirements of products and process optimization
  • Coordinate Design Change and Process Change activities
  • Develop design inputs and design outputs for changes to existing products
  • Provide R&D support for verification, qualification, and validation studies on existing products
  • Support risk management activities and risk management reviews on existing products
  • Provide R&D support for non-conformance investigations regarding component failures, finished goods failures, and product returns
  • Provide R&D support for customer complaints, including product/record investigation, health risk assessments, identification of CAPA’s, and report generation
  • Support regulatory approvals and responses to regulatory questions for existing products
  • Development of tests with human and animal tissue models
  • Other job duties as assigned

Requirements:

  • BS in Mechanical, Electrical or, Biomedical Engineering, or equivalent
  • Minimum of 2 years related experience and/or training
  • or equivalent combination of education and experience
  • Strong understanding of engineering concepts and principles
  • Familiar with device assembly, tolerancing, and possess basic drafting skills
  • Able to develop test protocols and synthesize data to write test reports based on observed data, relevant test standards and general engineering knowledge
  • Familiarity with statistical analysis (e.g. two-sample t-test, tolerance limit calculation)
  • Familiarity with FDA, ISO and EN Standards as they apply to medical devices
  • Ability to travel up to 10%

Nice to have:

  • Experience with IEC 60601 approved component changes
  • Experience with Class 3, active implantables
  • Familiarity with failure mode analysis and other risk management procedures (dFMEA, uFMEA, hazard analysis)
What we offer:
  • Comprehensive medical, dental, and vision insurance plans
  • Access to 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:
January 09, 2026

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