Senior Systems Engineer

2 days ago

Minneapolis, Minnesota, United States Cirtec Medical Corporation Full time
Job Title: Senior Systems Engineer

Cirtec Medical Corporation 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 62304, ISO 13485, and ISO 14971
  • 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 (preferably mechanical, electrical, or software engineering)
  • 2+ years of experience in an engineering environment with mechanical, tool design, and manufacturing processes (medical device experience preferred)
  • Meticulous attention to detail, including ability to maintain accurate records and traceability
  • Experience with Quality Control principles and methodology
  • Good communication and interpersonal skills
  • Analytical reasoning and problem-solving skills
  • Experience in developing requirements, engineering specifications, procedures
  • Team player and goal-oriented
  • Strong self-starting qualities to independently manage coordination of multiple projects to ensure timely and successful completion
  • Knowledge of Quality Management System principles and methodology
  • Knowledge of Agile development methodologies (Scrum, Kanban)
  • Engineering experience with active and passive implantable devices and peripherals for Class III medical devices
  • Prefer knowledge of SysML, UML, and MBSE, INCOSE ASEP or CSEP
  • JAMA Product Development Documentation Management experience helpful
  • Prefer experience in electronics: analog, power, and digital, oscilloscopes, general electronic test equipment
  • Must be able to read, write, and speak fluent English
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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