A Product Support, R&D Engineer will be responsible for performing a variety sustaining design tasks over a broad range of products inInterventional Urology. Contribute to fulfilling business goals of Coloplast for new products, current products and line extensions. This position will include labratory 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. Here is some of what you can expect:

• Health and Wellness: Comprehensive medical, dental, and vision insurance plans to keep you and your family healthy. Plus, 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.
• Financial Security: A competitive 401(k) plan with company match that vest immediately, financial planning services to help you secure your future, and corporate discount programs for goods and services.
• Work-Life Balance: Generous paid time off, flexible work hours, and flexible work arrangement options to help you balance your personal and professional life may be available.
• Professional Development: Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement.
• Recognition and Rewards: Recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events.
• Community and Culture: 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.
• Competitive Compensation: The compensation range for this position is $90,745 - $136,118. Actual compensation is influenced by a variety of factors including but not limited to skills, experience, qualifications, and geographic location. Hired candidates may be eligible to receive additional compensation in the form of bonuses and/or incentives.

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16,000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

Visit us on Coloplast.com.

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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.

Coloplast is committed to a policy of Equal Employment Opportunity (EEO) which means we employ and promote individuals based on their merits, regardless of race, color, religion, sex, national origin, age, disability, veteran status, pregnancy, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, status with regards to public assistance or any other protected classification.

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