R&D Engineer, Product Support

R&D Engineer, Product Support

Location: Minneapolis, MN, US

Job Family: Research & Development

Country/Region: United States

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.

Major Areas of Accountability:

• 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

Basic Qualifications:

• 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 Qualifications:

• 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)

At Coloplast, we believe in recognizing and rewarding the contributions of our employees. Our total rewards package is designed to support your well-being, foster your professional growth, and ensure a healthy work-life balance.