Principal Systems Engineer
Medtronic
- Fridley, MN
- Permanent
- Full-time
PELVIC HEALTH therapies treat patients suffering from overactive bladder, non-obstructive urinary retention and fecal incontinence with sacral neuromodulation and percutaneous tibial neuromodulation devices.A Day in the Life
Responsibilities may include the following and other duties may be assigned.
- Performs technical planning, system integration, , evaluates alternatives including cost and risk, supportability and analyses for total systems.
- Analyses are performed at all levels of total system product to include: concept, design, fabrication, test, installation, operation, maintenance and disposal.
- Ensures the logical and systematic conversion of product requirements into total systems solutions that acknowledge technical, schedule, and cost constraints.
- Performs functional analysis, timeline analysis, detail trade studies, requirements allocation and interface definition studies to translate customer requirements into hardware and software specifications.
- Defines the technologies, policies, and data models to be used in collecting, organizing, storing, and accessing information.
- Defines the integration of security, performance, maintainability, lifecycle, and data recovery inputs in the design and implementation of data management solutions.
- Autonomy: Recognized expert, managing large projects or processes.
- Exercises considerable latitude in determining deliverables of assignments, with limited oversight from manager.
- Coaches, reviews and delegates work to lower level specialists.
- Organizational Impact: Contributes to defining the direction for new products, processes, standards, or operational plans based on business strategy with a significant impact on work group results.
- May manage large projects or processes that span outside of immediate job area.
- Innovation and Complexity: Problems and issues faced are difficult, moderately complex and undefined, and require detailed information gathering, analysis and investigation.
- Develops solutions to moderately complex problems, and/or makes moderate to significant improvements of processes, systems or products independently to enhance performance of job area.
- Implements solutions to problems.
- Communication and Influence: Represents organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels.
- May negotiate with others to reach understanding or agreement, and influence decision-making.
- Leadership and Talent Management: Typically provides guidance, coaching and training to other employees within job area.
- Typically manages major / moderately complex projects, involving delegation of work and review of work products, at times acting as a team leader.
- Required Knowledge and Experience: Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience.
- May have broad knowledge of project management.
- Bachelors degree required in a technically related field
- Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience
- Bachelor’s degree in Computer Science, Computer Engineering, Biomedical Engineering, Electrical Engineering, or similar discipline
- Experience in Systems Engineering discipline or use of Systems Engineering methodologies
- Previous medical device experience with a history of developing products from technology to market release in an FDA regulated environment
- Previous experience establishing and maintaining information systems, IT, cloud infrastructure, health software and firmware designs
- Experience with designing APIs and the software to support those interfaces
- Experience working with and designing systems to meet ISO and Quality System Regulation requirements, including IEC-60601-1, -2, -6, IEC-62304, ISO-14971, FDA 21CFR820.30 for Class I, II and III medical systems
- Experience with data privacy (e.g. EU GDPR) regulations
- Experience with data processing and predictive analytics algorithms
- Demonstrated strong verbal/written communication
- Experience working in cross-functional and team environments
- Posting Date: May 6, 2024
- Travel: Yes,
- Salary Min: 128000.00
- Salary Max: 192000.00