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Systems Engineer

Location: 

Minneapolis, US

Job Family:  Research & Development
Country/Region:  United States

Systems Engineer 

Coloplast has an exciting opportunity for a Systems Engineer to join our growing team!

 

The Interventional Urology Systems Engineer is responsible for supporting new product development and existing designs by using a systems approach to ensure all products meet the customer requirements, standards requirements, quality systems and global regulations.

 

Major Areas of Accountability

  • Lead the development of the systems architecture for the product
  • Manage product requirements within an electronic tracing system – verifies requirements and their flow through the system hierarchy
  • Create standards checklist for products and follows through to compliance
  • Create and maintains design history file for products from development through product lifecycle
  • Ensure customer needs/business needs are translated into clear and concise system requirements
  • Work with design engineers to translate system requirements and system risk analyses into component-level requirements, designs and risk management approaches
  • Support product risk management activities including risk management plan, preliminary risk analysis, risk analysis and risk management report
  • Support design validation related activities and human factors usability studies to ensure successful validation of user needs and intended use along with associated risk control mitigations
  • Provide technical support based on overall project plans with the development of products in compliance with design controls, international standards, FDA or other regulatory body guidances, and regulations
  • Actively participates on cross-functional teams to develop new devices as well as address design changes to existing products
  • Provide support to Clinical for risk management elements of the Clinical Evaluation Report
  • Provide support to Regulatory for submissions and competent authority/notified body responses
  • Provide support for Post Market Surveillance activities related to risk management
  • Create trace from customer requirements, standards and risk analysis through the system hierarchy
  • Conform with Coloplast Code of Conduct and all local Compliance Standards
  • Conform with Coloplast Q/EHS Policy
  • Other duties as assigned

 

Basic Qualifications

  • BS in Engineering (Mechanical preferred)
  • Minimum of 3-5 years related experience and/or training
  • Prior experience with applying design controls (including risk management) in a medical device design, manufacturing and transfer environment
  • Technical writing skills
  • Knowledge and application of FDA, QSR, ISO 13485 and ISO 14971 requirements
  • Effective problem-solving skills
  • Understanding of engineering concepts and principles
  • Familiarity with hazard analysis, failure mode analysis (FMEA, Fault Tree Analysis) and other risk management processes
  • Ability to travel up to 10%
  • Ability to work independently
  • Ability to take verbal instructions and translate them into goals and objectives
  • Strong written and verbal communication

 

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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