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Principal R&D Engineer

Location: 

Minneapolis, US

Job Family:  Research & Development
Country/Region:  United States
Principal R&D Engineer 

 

Coloplast has an exciting opportunity for an R&D Engineer to join our growing team!

 

This position is responsible for performing original design, verification and validation over a broad range of technologies to provide new or improved products to the medical device market in the arena of Interventional Urology.  The Principal Engineer will act as technical lead for cross-functional product development teams executing new product and line extension projects to fulfill the business goals of Coloplast.  This position will interact with Coloplast personnel, external physicians, and external contract manufacturers and suppliers, throughout the entire development cycle.  Significant laboratory work will be required at times.

 

Major Areas of Accountability:

  • Perform original and iterative design for surgical urology devices
  • Provide technical guidance and support based on overall project plans with the development of products in compliance with design controls and processes in compliance with Good Manufacturing Practices (GMP).
  • Complete relevant tasks in order to fulfill major milestones including:  identification of design specifications, risk analysis, identifying processing parameters, materials, verification methods, validation methods, equipment requirements of new products and initial process optimization.
  • Create, obtain and maintain all necessary documentation throughout the development cycle for assigned projects by various means of recording.
  • Generate new intellectual property in accord with departmental strategic objectives.
  • Assure risk mitigation through robust design of implantable devices
  • Develop proper verification tests and validation of such.  Tests may include both human and animal tissue models
  • If this position is assigned any responsibilities associated with our hazardous waste handling, then refer to the document Hazardous Waste Job Responsibilities for detailed duties.    
  • 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; Master’s or PhD in stated disciplines preferred
  • 10+ years related experience and/or training; or equivalent combination of education and experience – Class III medical device experience preferred
  • Understanding of advanced engineering concepts and principles.
  • Experience with device assembly, tolerancing, and possess basic drafting skills
  • Experience with prototyping methods
  • Good understanding of materials as they relate to medical devices.
  • Experience in project management
  • Able to develop test protocols and synthesize data to write test reports based on observed data, relevant test standards and general engineering knowledge.
  • Good understanding of statistical analysis (e.g. normality, two-sample t-test, tolerance limit calculation, etc.)
  • Familiarity with FDA, ISO and EN Standards as they apply to medical devices.
  • Experience with failure mode analysis (FMEA, Fault Tree Analysis), hazard analysis and other risk management procedures.
  • Experience with design control process and procedures, including customer requirement generation, design inputs and outputs, and verification and validation
  • Good understanding of usability engineering
  • Solid understanding of Quality Management Systems and standard operating procedures
  • Ability to travel up to 30%

 

Required Knowledge, Skills and Abilities:

  • Ability to work independently or as a technical lead
  • Ability to take verbal instructions and translate them into goals and objectives.
  • Good written and verbal communication.
  • Able to direct others in the completion of their tasks (e.g., technicians, lower-level engineers or scientists).
  • Innovative with respect to developing product concepts and test methods.
  • Pro-active; high-performance and results orientation
  • Ability to consistently work, manage and lead with ethical integrity
  • Personifies Coloplast Mission, Values and Vision as well as Coloplast Leadership Principals

 

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 12,000 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.

Watch the film. Follow us on LinkedIn. Like us on Facebook.

 

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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Nearest Major Market: Minneapolis

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