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Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. We deliver outstanding results and innovative solutions in the Medical Device and Medical Supplies segments. Through progressive thinking and cutting-edge technologies, Covidien is well positioned to lead the way in today's rapidly changing healthcare industry. Whatever your specialty or ambitions, you can make a difference at Covidien - both in the lives of others and your career.
At Covidien, we strive to fully understand our marketplace, customers, communities and employees, and we enter into relationships with a sense of honesty, fairness and trust.
We are an affirmative action/equal opportunity employer.
SUMMARY OF POSITION :
The Systems and Verification Engineer will be a member of the Covidiein R&D engineering team working in the development and support of Covidien Respiratory and Patient Monitoring products. Systems and Verification Engineers are expected to work with other members of the engineering staff to provide technical expertise and solutions to engineering problems.
The Systems and Verification Engineer will participate in the creation of product requirements, high level systems architecture, electrical hardware requirements, firmware requirements, and software requirements.
The Systems and Verification Engineer will also participate in designing, developing and implementing methods of testing and troubleshooting products under development.
LOCATION: Boulder, CO. Relocation assistance is not available for this role.
ESSENTIAL FUNCTIONS :
Participates, as a member of systems project team, in the development of system requirements and architecture.
Flows down system requirements to sub-systems.
Adheres to defined development processes and procedures.
Write clear, concise testing and engineering documents, including test protocols/procedures, test reports, as well as other communications to other parts of the organization.
Demonstrate ability and desire to work within a regulated medical device development environment, particularly based on the FDA Quality System Regulation and ISO 13485.
Demonstrate competency in at least one Engineering discipline (primarily electrical or software), with desire to learn aspects of the other disciplines to grow as a system and verification engineer.
Work with senior test engineers to design and/or develop testing methods and tools to assure products meet requirements for performance and safety.
Work within project teams to complete product testing on time and within budget.
Demonstrate knowledge of UL-, CSA- and IEC-based standards related to medical device product development and work with compliance and safety engineers and testing vendors to complete associated product tests.
Investigate new technological developments to evaluate their potential advantages to the organization.
Good writing, speaking and organizational skills essential
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS :
Participates in activities, such as performing hazard and risk analysis, reviews of designs and tests, etc.
Supports hardware, software and sub-sysetm level verification and validation testing.
May provide hardware and firmware development support on existing products.
May work on process improvement activities.
Attend and contribute to department meetings
Other duties as assigned with or without accommodation.
MINIMUM REQUIREMENTS :
EDUCATION: Bachelor of Science degree in Electrical Engineering, Computer Science, Computer Engineering, Biomedical Engineering or other related technical field.
EXPERIENCE: 0-2 years of Systems Engineering or technical Verification testing experience in a structured and/or regulated (preferably medical device) product development or testing environment.
Knowledgeable and experience in hardware and software development and the processes associated with product life-cycles.
Familiarity with and working knowledge of automated requirements management tools such as Doors, Rational Requisite Pro, etc.
Experience with automation test tools and techniques such as LabVIEW, TestStand, etc.
Experience testing systems involving both hardware and software components.
Creative problem solver, ability to prioritize according to risk needs
Excellent written and verbal communication skills.
Demonstrate level of technical competency in the Software or Electrical Engineering disciplines, with a secondary working knowledge of at least one other engineering discipline.
Prior knowledge of the FDA Quality System Regulation and/or ISO 13485 is a plus.
Good communication skills.
Self motivated and able to work in a cross functional team environment.
ORGANIZATIONAL RELATIONSHIPS/SCOPE :
Reports to the Manager, Systems Engineering and Design Verification & Validation for functional leadership. Accountable to a Principal Systems Engineer(s) and/or Project Manager(s) for project-related responsibilities.
Frequent interaction with team members from other disciplines, particularly hardware and software engineers, to understand project requirements and to adhere to project schedules. Possible interaction with clinicians, third-party vendors, manufacturers, subcontractors and other users.
WORKING CONDITIONS : Normal office and testing laboratory conditions
DISCLAIMER : The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
The Energy-based Devices Global Business Unit of Covidien is the world leader in the innovation and manufacture of advanced energy-based medical systems. Founded in 1967, our company remains unsurpassed in developing electrosurgery and radiofrequency treatment systems that increase patient safety and provide solutions for challenging surgical problems.
Covidien’s Energy-based Devices Global Business Unit has maintained a campus in Boulder, Colorado for 40 years and continues to build a culture rich in organic growth and development worldwide. Our company places a strong emphasis on people, products, and process to continue driving our success. More information can be found at www.covidien.com.