Coloplast · 1 day ago
R&D Engineer, Product Support
Minneapolis, MN
Full-time
Onsite
Entry, Mid Level
$91K/yr - $136K/yr
2+ years expColoplast is a leading medical device company that develops and markets products for intimate healthcare needs. The R&D Engineer, Product Support will perform sustaining design tasks across a range of products, ensuring compliance with design controls and good manufacturing practices while providing technical support and coordinating design change activities.
Health CareManufacturingMedical Device
Responsibilities
Provide technical support based on project plans with both new development products and commercialized products. All in compliance with design controls and processes in compliance with good manufacturing practices
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
Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies
Other job duties as assigned
Qualification
Required
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%
Preferred
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)
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
2025-12-05
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