Coloplast · 1 day ago
Senior Design Assurance Engineer
Minneapolis, MN
Full-time
Onsite
Mid, Senior Level
$106K/yr - $159K/yr
5+ years expColoplast is a leading medical device company that develops and markets products for intimate healthcare needs. The Interventional Urology Senior Design Assurance Engineer will support new product development and ensure compliance with design controls and regulatory standards.
Health CareManufacturingMedical Device
Responsibilities
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
Qualification
Required
BS in Engineering (Biomedical or Mechanical preferred)
5+ years related experience and/or training
Preferred
ASQ Certified Quality Engineer
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.
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.
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.
Company
Coloplast
Coloplast is a manufacturer of medical devices that offers ostomy, continence, and wound care products.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$1.34B2023-08-29Post Ipo Equity· $1.34B
2000-02-04IPO
Leadership Team
Lars Rasmussen
Chairman of the Board of Directors
Recent News
Essential Business
2025-12-20
2025-12-18
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