Systems Engineer II

Careers that Change Lives

A Day in The Life

Medtronic is looking for a Systems Engineer II to join the Systems Engineering Team within the newly formed Surgical Operation Unit. This role will collaborate across the Surgical OU Research and Development organization to bring innovative new medical devices to patients. The successful candidate will work with a cross functional team to assist in functional decompositions, customer and product requirement development, and system and subsystem architecture documentation. She or he will also engage in the execution and documentation of trade-off studies, prototype evaluations, and clinical acceptability studies.

Responsibilities may include the following and other duties may be assigned: • Assist in requirements development and traceability • Contribute to functional analysis and decomposition • Document system and subsystem architecture • Engage with design quality assurance in risk management activities • Employ Model Based Systems Engineering to document and communicate system design • Investigate system integration issues to identify root cause and propose resolution • Hands-on work with products in simulated use environments • Work closely with verification and validation engineers to review and refine test methods, protocols, and reports • Support Systems Engineering activities throughout the product lifecycle including design change impact analysis, labelling and packaging requirements, field issue investigation

Must Have: Minimum Requirements

• Working knowledge of Systems Engineering principals and best practices
• Strong communication skills
• Experience in new product development
• Experience developing complex electromechanical medical devices
• Experience with design controls and good documentation practices
• Awareness of standards including IEC 60601, ISO 14971, ISO 13485 and 62366
• Bachelor's degree in Biomedical, Electrical, Mechanical, or Systems Engineering required
• Minimum of 2 years of relevant experience, or advanced degree in engineering discipline
• Fluency in English required

Nice to Have

• Advanced degree in Biomedical, Electrical, Mechanical, or Systems Engineering
• Minimum of 2 years' experience as a contributing member to engineering projects
• Strong organization acumen with the ability to communicate effectively to non-technical audiences
• Demonstrated ability to collaborate and contribute to a cross functional product development team
• Knowledge of requirements management, risk management, and system architecture documentation
• Familiarity with tools such as Enterprise Architect, Jira, Jama, and Oracle Agile.
• Experience working on products of high complexity in a regulated environment
• Understanding of structured product development

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)