Lead Systems Engineer

2 weeks ago

Brooklyn Park, Minnesota, United States Cirtec Medical Full time

Sign-On Bonus: This position is eligible for a $5,000 sign-on bonus.

Location: This position is based on-site at our corporate headquarters.

ABOUT CIRTEC MEDICAL

Cirtec Medical is not just another design firm or contract manufacturer; we provide a uniquely comprehensive suite of vertically integrated capabilities. Our expertise lies in producing complex components and devices across advanced product technologies, including neuromodulation, implantable drug delivery, cardiac rhythm management, and interventional devices.

Our team possesses the skills necessary to innovate device designs, tackle intricate design challenges, and assist in bringing our clients' products to market. If you thrive in a dynamic, challenging environment with a company that is expanding and pioneering cutting-edge technology, Cirtec is the right fit for you.

TEAM STRUCTURE:

The Engineering team is composed of professionals with diverse backgrounds and skills. They collaborate closely with Operations, R&D, and Purchasing. Your role will involve the design, development, documentation, and validation of new customer products, as well as modifications to existing products. This includes defining requirements, timelines, and deliverables, with a focus on prototypes, process development, design verification, clinical builds, and preparing for manufacturing transfer.

POSITION SUMMARY:

The Senior Systems Engineer will oversee system-level development and implementation of electronic and software designs for Class II and III medical devices. You will collaborate with a multi-disciplinary engineering team, including software, electrical, and mechanical engineers, ensuring high-quality and timely product introductions. This role requires a proactive individual capable of managing multiple projects efficiently in a fast-paced environment.

KEY RESPONSIBILITIES:

  • Develop requirements, engineering specifications, and tests throughout the product lifecycle.
  • Apply medical development standards, such as IEC 62304 and ISO 13485.
  • Ensure compliance with hardware and software requirements, maximizing performance and reliability within project constraints.
  • Conduct detailed design analysis and regular design reviews with engineering teams.
  • Collaborate with program managers to create and manage development and project plans.
  • Lead the creation of risk management documentation, including Failure Mode Effects Analysis.
  • Maintain comprehensive documentation for medical product Design History Files.
  • Create and review test software requirements and execute test code.
  • Participate in product development meetings and design reviews.
  • Specify and assemble hardware for testing purposes.
  • Maintain design history files and participate in periodic phase reviews.
  • Generate reports for stakeholders and maintain test logs.
  • Provide insights to enhance medical device design and testing outcomes.
  • Employ a systematic approach to problem-solving.
  • Adhere to company quality and safety standards.
  • Perform additional duties as assigned.

QUALIFICATIONS:

  • Bachelor’s degree in a STEM discipline and a minimum of 5 years of relevant experience.
  • Experience in an engineering environment, particularly in medical device manufacturing.
  • Strong attention to detail and ability to maintain accurate records.
  • Familiarity with Quality Control principles and methodologies.
  • Excellent communication and interpersonal skills.
  • Strong analytical and problem-solving abilities.
  • Knowledge of Agile development methodologies.
  • Proficiency in English, both written and spoken.
  • Preferred experience with Class III medical devices and implantable technologies.
  • Familiarity with SysML, UML, and MBSE is advantageous.
  • Experience with electronic testing equipment is a plus.

BENEFITS:

  • A dynamic work environment.
  • Paid time off.
  • 401(k) retirement savings plan with company matching.
  • Clean and well-maintained production areas.
  • Opportunities for training and career development.
  • Comprehensive health care and wellness programs.

WORKING ENVIRONMENT:

The work is conducted in an office setting with a moderate noise level.

EEO STATEMENT:

Cirtec Medical Corporation is an Equal Opportunity Employer, considering qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran status, or disability status.

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