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Senior Systems Engineer

2 months ago

Minneapolis, Minnesota, United States Cirtec Medical Full time
About the Role

Cirtec Medical is seeking a highly skilled Systems Engineer II to join our Engineering team. As a key member of our team, you will be responsible for the system-level development and implementation of electronic and software designs for Class II and III medical devices.

Key Responsibilities
  • Create requirements, engineering specifications, and tests during the product development life cycle.
  • 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. Manage and assist in the creation of manufacturing process instructions, bills of material, quality inspection, and related documentation.
  • 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
  • A Bachelor's degree (STEM engineering discipline preferred) and 2 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.
  • Must have 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.