Medtronic Plc
Principal Systems Engineer - Pelvic Health
Medtronic Plc, Minneapolis, Minnesota, United States, 55400
Principal Systems Engineer
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. In this exciting role as a Principal Systems Engineer, you will be responsible for leading the development of our new tibial neurostimulator system solutions. You will act as a technical leader working within a matrix organization to support the Systems Engineering organization in the definition, design, development, and testing of complex medical device systems within the Pelvic Health Operating Unit. System designs typically include a mix of consumer and medical technologies involving electronic circuits, batteries, software, wireless communication, and supporting network services. Next-generation systems are developed with a user-centered design approach, ensuring innovative solutions that meet marketplace needs. Pelvic Health therapies treat patients suffering from overactive bladder, non-obstructive urinary retention and fecal incontinence with sacral neuromodulation and percutaneous tibial neuromodulation devices. Responsibilities may include the following and other duties may be assigned: Perform technical planning, system design and architecture, 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. Define and/or review requirements for implantable medical device systems that meet the expectations and uses of the customer, regulatory agencies, and the business. Ensure the logical and systematic conversion of product requirements into total systems solutions that acknowledge technical, schedule, and cost constraints. Perform functional analysis, timeline analysis, detail trade studies, requirements allocation and interface definition studies to translate customer requirements into hardware and software specifications. Lead technical architecture activities to drive complete system definition, establish performance metrics, and define system interfaces. Perform/participate in Risk Analysis activities, such as FMEAs and Hazard Analyses, for systems, features, and implementations with the intent to eliminate or mitigate the risks in the identified scenarios. Provide support to customers and clients for Pelvic Health systems during and after launch. Identify and resolve product issues both internally during product development and post launch if field issues arise. Act as a team leader to manage major/moderately complex projects, involving delegation of work and review of work products. Provide guidance, coaching, and training to other employees within job area. Establish and advocate for best practices and continuous improvement to mature systems engineering knowledge and processes. Champion consistent implementation of the Quality System across projects. Technical Specialist Career Stream: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies from design to implementation - while adhering to policies, using specialized knowledge and skills. Differentiating Factors 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. Must Have: Minimum Requirements Requires a Baccalaureate degree Minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience. To be considered for this role, please ensure the minimum requirements are evident on your resume. Nice to Have 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, including Systems Modeling Language (SysML) Previous medical device experience with a history of developing products from technology to market release in an FDA regulated environment Experience with designing for the hardware/software/communication interfaces of electronic devices Strong software background with understanding of database structure and using APIs to interface with databases 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 Demonstrated strong verbal/written communication skills Demonstrated ability to make decisions quickly and guide a team through complex problems Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 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. Benefits & Compensation Medtronic offers a competitive salary and flexible benefits package. A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD): $128,000.00 - $192,000.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. In this exciting role as a Principal Systems Engineer, you will be responsible for leading the development of our new tibial neurostimulator system solutions. You will act as a technical leader working within a matrix organization to support the Systems Engineering organization in the definition, design, development, and testing of complex medical device systems within the Pelvic Health Operating Unit. System designs typically include a mix of consumer and medical technologies involving electronic circuits, batteries, software, wireless communication, and supporting network services. Next-generation systems are developed with a user-centered design approach, ensuring innovative solutions that meet marketplace needs. Pelvic Health therapies treat patients suffering from overactive bladder, non-obstructive urinary retention and fecal incontinence with sacral neuromodulation and percutaneous tibial neuromodulation devices. Responsibilities may include the following and other duties may be assigned: Perform technical planning, system design and architecture, 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. Define and/or review requirements for implantable medical device systems that meet the expectations and uses of the customer, regulatory agencies, and the business. Ensure the logical and systematic conversion of product requirements into total systems solutions that acknowledge technical, schedule, and cost constraints. Perform functional analysis, timeline analysis, detail trade studies, requirements allocation and interface definition studies to translate customer requirements into hardware and software specifications. Lead technical architecture activities to drive complete system definition, establish performance metrics, and define system interfaces. Perform/participate in Risk Analysis activities, such as FMEAs and Hazard Analyses, for systems, features, and implementations with the intent to eliminate or mitigate the risks in the identified scenarios. Provide support to customers and clients for Pelvic Health systems during and after launch. Identify and resolve product issues both internally during product development and post launch if field issues arise. Act as a team leader to manage major/moderately complex projects, involving delegation of work and review of work products. Provide guidance, coaching, and training to other employees within job area. Establish and advocate for best practices and continuous improvement to mature systems engineering knowledge and processes. Champion consistent implementation of the Quality System across projects. Technical Specialist Career Stream: An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies from design to implementation - while adhering to policies, using specialized knowledge and skills. Differentiating Factors 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. Must Have: Minimum Requirements Requires a Baccalaureate degree Minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience. To be considered for this role, please ensure the minimum requirements are evident on your resume. Nice to Have 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, including Systems Modeling Language (SysML) Previous medical device experience with a history of developing products from technology to market release in an FDA regulated environment Experience with designing for the hardware/software/communication interfaces of electronic devices Strong software background with understanding of database structure and using APIs to interface with databases 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 Demonstrated strong verbal/written communication skills Demonstrated ability to make decisions quickly and guide a team through complex problems Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 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. Benefits & Compensation Medtronic offers a competitive salary and flexible benefits package. A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Salary ranges for U.S (excl. PR) locations (USD): $128,000.00 - $192,000.00 This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others). The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). The following benefits and additional compensation are available to all regular employees: Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums). Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to