Summary:

Based out of our headquarters in Brooklyn Park, MN, the Sr. Systems Engineer will be responsible for system-level development and implementation of electronic and software designs for Class II and III medical devices. The Systems Engineer will work with a multi-disciplinary engineering team including software, electrical and mechanical hardware engineers and all other functions of the company to ensure high quality and on-time product introductions. This team player will have experience with multi-tasking in a high energy fast paced environment. The person needs to have strong self-starting qualities to independently manage coordination of multiple projects to ensure timely and successful completion. Must be enthusiastic, positive, even tempered and have strong skills in areas of dependability, interpersonal relationships, and communication.

Responsibilities:

• Create requirements, engineering specifications, tests during the life cycle of the product development
• Applies medical development standards, such as IEC 60601-1, 62304, 60601-1-2, ISO 14708-1, 14708-3, ISO 13485
• Ensure that all hardware and software requirements and specifications are being met, and that all elements are being developed to maximize performance, reliability and serviceability within the constraints of 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 in creation of risk management documentation, including Failure Mode Effects Analysis
• Develop and maintain documentation (e.g. specifications, designs, test plans and reports, etc.) required for medical product Design History Files. Manage and assist in creation of ­manufacturing process instructions, bills of material, quality inspection, and related documentation
• Create, review test software requirements, architecture, develop and executing the test code.
• Knowledge of Quality Management System principles and methodology
• Participate in product development meetings and software/hardware design and risk analysis reviews.
• Specify and assemble hardware for tests
• Maintain design history file and participate in periodic phase reviews.
• Create reports to the stakeholders and create test logs.
• Provide inputs to the team in order to improve the medical device design and test outcomes.
• Use a thorough, systematic, open approach to problem-solving.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Qualifications:

• BS in Electrical Engineering, Computer Engineering, or Systems Engineering or in an equivalent engineering discipline.
• Minimum of 3 years’ experience in a regulated development environment.
• 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)
• Excellent oral, written, and presentation communication skills

PREFERRED QUALIFICATIONS:

• Engineering experience with active and passive implantable devices and peripherals for Class III medical devices.
• SysML, UML and MBSE
• INCOSE ASEP or CSEP
• JAMA Product Development Documentation Management
• Experienced in electronics: analog, power and digital, oscilloscopes, general electronic test equipment.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is frequently required to sit, talk and/or hear, and/or use hands to finger, handle, or touch objects, tools, or controls. The employee is occasionally required to stand, and/or walk. The employee must occasionally lift and/or move up to 10 pounds while moving files or small packages. The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.

Please click here to apply.