Coloplast

Senior Design Assurance Engineer

Coloplast

full-time

Posted on:

Location Type: Office

Location: Minneapolis • Minnesota • United States

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Salary

💰 $105,868 - $158,802 per year

Job Level

Senior

About the role

  • 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%.
Benefits
  • Comprehensive medical, dental, and vision insurance plans to keep you and your family healthy.
  • Access to company sponsored wellness programs and mental health resources.
  • Paid leave of absence for qualifying events and generous paid parental leave for both birthing and non-birthing parents.
  • A competitive 401(k) plan with company match that vest immediately.
  • Financial planning services to help you secure your future.
  • Corporate discount programs for goods and services.
  • Generous paid time off, flexible work hours, and flexible work arrangement options to help you balance your personal and professional life may be available.
  • 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 where everyone feels valued, and has a sense of belonging.
  • Participate in team-building activities, volunteer opportunities, and company-sponsored events.
  • Sustainability strategy that outlines our ambitions for how to run our company in a more sustainable way.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
design controlsrisk managementtest method validationstatistical analysisdesign verificationdesign validationHazard AnalysisDFMEAPFMEAUFMEA
Soft Skills
independent worktask managementteam leadershipwritten communicationverbal communicationtechnical writingproblem-solvingorganizational skills
Certifications
BS in EngineeringASQ Certified Quality Engineer