Medtronic
Principal Systems Engineer - Pelvic Health
Medtronic, Minneapolis, Minnesota, United States, 55400
Overview
We anticipate the application window for this opening will close on 26 Sep 2025. 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. Role
Principal Systems Engineer
— lead the development of tibial neurostimulator system solutions within the Pelvic Health Operating Unit. Act as a technical leader in a matrix organization to support Systems Engineering in the definition, design, development, and testing of complex medical device systems. 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 to meet marketplace needs. Pelvic Health therapies
treat patients with overactive bladder, non-obstructive urinary retention and fecal incontinence using sacral neuromodulation and percutaneous tibial neuromodulation devices. Responsibilities
Perform technical planning, system design and architecture; evaluate alternatives including cost, risk, supportability, and analyses for total systems. Analyze all levels of total system product life cycle: concept, design, fabrication, test, installation, operation, maintenance and disposal. Define and/or review requirements for implantable medical device systems that meet customer, regulatory, and business expectations. Ensure logical and systematic conversion of product requirements into total system solutions, considering 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 or participate in risk analysis activities (e.g., FMEAs, Hazard Analyses) to mitigate identified risks. Provide support to customers and clients for Pelvic Health systems during and after launch. Identify and resolve product issues during development and post-launch if field issues arise. Act as a team leader to manage major or moderately complex projects, including delegation of work and review of work products. Provide guidance, coaching, and training to other employees within the job area. Establish and advocate best practices and continuous improvement to mature Systems Engineering knowledge and processes. Champion consistent implementation of the Quality System across projects. Qualifications
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 SysML Previous medical device experience with development from technology to market release in an FDA-regulated environment Experience with designing hardware/software/communication interfaces of electronic devices Strong software background with understanding of database structure and using APIs to interface with databases Experience meeting ISO and Quality System Regulation requirements (IEC 60601-1, -2, -6, IEC 62304, ISO 14971, FDA 21 CFR 820.30 for Class I-III medical systems) Experience with data privacy regulations (e.g., EU GDPR) Demonstrated strong verbal and written communication skills Ability to make quick decisions and guide a team through complex problems Physical Job Requirements The physical demands described are representative of those required to perform the essential functions of this job. Reasonable accommodations may be made for individuals with disabilities. Benefits & Compensation
Medtronic offers a competitive salary and flexible benefits package. We provide a range of benefits and compensation plans designed to support you at every career and life stage. Specific US salary information is provided below for eligible candidates. Salary ranges for U.S. locations (USD): $128,000.00 - $192,000.00 Eligible for Medtronic Incentive Plan (MIP); base salary varies by experience, certification/education, market conditions, and location Benefits for regular employees (20+ hours/week): Health, dental, vision; HSA; Healthcare FSA; life insurance; long-term disability leave; dependent care spending account; tuition assistance/reimbursement; and wellbeing program Additional benefits for regular employees: 401(k) with employer match; short-term disability; PTO; paid holidays; Employee Stock Purchase Plan; Employee Assistance Program; and Capital Accumulation Plan (eligible roles) For more details, see the Medtronic benefits and compensation plans. About Medtronic
We lead global healthcare technology and tackle challenging health problems by searching for solutions. Our mission is to alleviate pain, restore health, and extend life. We are engineers at heart, turning ambitious ideas into real solutions. Learn more about our business and commitment to diversity. Medtronic is an equal employment opportunity employer. We provide reasonable accommodations for qualified individuals with disabilities.
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We anticipate the application window for this opening will close on 26 Sep 2025. 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. Role
Principal Systems Engineer
— lead the development of tibial neurostimulator system solutions within the Pelvic Health Operating Unit. Act as a technical leader in a matrix organization to support Systems Engineering in the definition, design, development, and testing of complex medical device systems. 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 to meet marketplace needs. Pelvic Health therapies
treat patients with overactive bladder, non-obstructive urinary retention and fecal incontinence using sacral neuromodulation and percutaneous tibial neuromodulation devices. Responsibilities
Perform technical planning, system design and architecture; evaluate alternatives including cost, risk, supportability, and analyses for total systems. Analyze all levels of total system product life cycle: concept, design, fabrication, test, installation, operation, maintenance and disposal. Define and/or review requirements for implantable medical device systems that meet customer, regulatory, and business expectations. Ensure logical and systematic conversion of product requirements into total system solutions, considering 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 or participate in risk analysis activities (e.g., FMEAs, Hazard Analyses) to mitigate identified risks. Provide support to customers and clients for Pelvic Health systems during and after launch. Identify and resolve product issues during development and post-launch if field issues arise. Act as a team leader to manage major or moderately complex projects, including delegation of work and review of work products. Provide guidance, coaching, and training to other employees within the job area. Establish and advocate best practices and continuous improvement to mature Systems Engineering knowledge and processes. Champion consistent implementation of the Quality System across projects. Qualifications
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 SysML Previous medical device experience with development from technology to market release in an FDA-regulated environment Experience with designing hardware/software/communication interfaces of electronic devices Strong software background with understanding of database structure and using APIs to interface with databases Experience meeting ISO and Quality System Regulation requirements (IEC 60601-1, -2, -6, IEC 62304, ISO 14971, FDA 21 CFR 820.30 for Class I-III medical systems) Experience with data privacy regulations (e.g., EU GDPR) Demonstrated strong verbal and written communication skills Ability to make quick decisions and guide a team through complex problems Physical Job Requirements The physical demands described are representative of those required to perform the essential functions of this job. Reasonable accommodations may be made for individuals with disabilities. Benefits & Compensation
Medtronic offers a competitive salary and flexible benefits package. We provide a range of benefits and compensation plans designed to support you at every career and life stage. Specific US salary information is provided below for eligible candidates. Salary ranges for U.S. locations (USD): $128,000.00 - $192,000.00 Eligible for Medtronic Incentive Plan (MIP); base salary varies by experience, certification/education, market conditions, and location Benefits for regular employees (20+ hours/week): Health, dental, vision; HSA; Healthcare FSA; life insurance; long-term disability leave; dependent care spending account; tuition assistance/reimbursement; and wellbeing program Additional benefits for regular employees: 401(k) with employer match; short-term disability; PTO; paid holidays; Employee Stock Purchase Plan; Employee Assistance Program; and Capital Accumulation Plan (eligible roles) For more details, see the Medtronic benefits and compensation plans. About Medtronic
We lead global healthcare technology and tackle challenging health problems by searching for solutions. Our mission is to alleviate pain, restore health, and extend life. We are engineers at heart, turning ambitious ideas into real solutions. Learn more about our business and commitment to diversity. Medtronic is an equal employment opportunity employer. We provide reasonable accommodations for qualified individuals with disabilities.
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