Senior Systems Engineer

1 month ago

Brooklyn Park, Minnesota, United States Cirtec Medical Full time
About the Job

Cirtec Medical is seeking a highly skilled Senior Systems Engineer to join our team. As a key member of our Engineering team, you will be responsible for designing, developing, and implementing electronic and software systems for Class II and III medical devices.

Key Responsibilities
  • Create requirements, engineering specifications, and tests during the product development lifecycle
  • Apply medical development standards, such as IEC 60601-1, 62304, and ISO 13485
  • Ensure that all hardware and software requirements and specifications are met, and that all elements are developed to maximize performance, reliability, and serviceability within the project schedule and budget
  • Perform detailed design analysis and conduct regular design reviews with hardware and software engineering teams
  • Collaborate with program managers to create and manage development plans and project plans related to electronic and software systems development
  • Lead and contribute to the creation of risk management documentation, including Failure Mode Effects Analysis
  • Develop and maintain documentation required for medical product Design History Files
  • Create, review, and execute test software requirements, architecture, and test code
  • Participate in product development meetings and software/hardware design and risk analysis reviews
  • Specify and assemble hardware for tests
  • Maintain design history files and participate in periodic phase reviews
  • Create reports to stakeholders and create test logs
  • Provide inputs to the team to improve medical device design and test outcomes
Requirements
  • Bachelor's degree in a STEM engineering discipline (preferred) and 5 years of experience required; or a combination of education and relevant work experience
  • Experience in an engineering environment with mechanical, tool design, and manufacturing processes (medical device preferred)
  • Meticulous attention to detail, including ability to maintain accurate records and traceability
  • Experienced with Quality Control principles and methodology
  • Good Communication and interpersonal skills
  • Analytical reasoning and problem-solving
  • Experience in developing requirements, engineering specifications, procedures
  • Team player and goal-oriented
  • Knowledge of Agile development methodologies (Scrum, Kanban)
  • Must be able to read, write, and speak fluent English
  • Knowledge of Quality Management System principles and methodology
  • Excellent oral, written, and presentation communication skills
  • Prefer Engineering experience with active and passive implantable devices and peripherals for Class III medical devices
  • SysML, UML, and MBSE, INCOSE ASEP or CSEP preferred
  • JAMA Product Development Documentation Management helpful
  • Prefer experience in electronics: analog, power, and digital, oscilloscopes, general electronic test equipment
What We Offer
  • A fast-paced work environment
  • Paid time off
  • 401(k) retirement savings with a company match
  • Clean, well-lit production areas
  • Training and career development, with onboarding programs for new employees and tuition assistance
  • Financial security through competitive compensation, incentives, and retirement plans
  • Health care and well-being programs, including medical, dental, vision, wellness, and occupational health programs
Working Environment

Work is performed in an office environment. The noise level in the work environment is usually moderate.

EEO Statement

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer. Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran, or disability status or any factor prohibited by law.

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