Principal R&D Engineer

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The Principal Engineer will act as technical lead for cross-functional product development teams executing new product and line extension projects..  This position will interact with Coloplast personnel, external physicians, and external contract manufacturers and suppliers, throughout the entire development cycle. 

 

Major Areas of Accountability:

• Perform original and iterative design for Interventional Urology implantable and active implantable devices.
• Lead a team through the design control process and procedures, including customer requirement generation, design inputs and outputs, and verification.
• Complete relevant tasks to fulfill major program milestones by partnering with Project Management to ensure activities are planned out for the technical team.
• Create and maintain all necessary documentation throughout the development cycle for assigned projects.
• Assure risk mitigation through robust design and detailed product requirements.
• Conform with Coloplast Code of Conduct and all local Compliance Standards
• Conform with Coloplast Q/EHS Policy
• Other duties as assigned

 

Essential Qualifications:

• Bachelor’s Degree in Mechanical Engineering or Bio-Medical with a focus on Mechanical Engineering
• 7+ years related experience and/or training; or equivalent combination of education and experience – Class III medical device experience
• Understanding of advanced engineering concepts and principles.
• Experience with device assembly, tolerancing, and possess basic drafting skills
• Good understanding of materials as they relate to medical devices.
• 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 FDA, ISO and EN Standards as they apply to medical devices.
• Ability to travel up to 10%

 

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Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 14,000 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 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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