Manager, Systems Engineering
Manager, Systems Engineering
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1 Vacancy
Job Description
We are seeking an exceptional Systems Engineering Manager with a background in electrical engineering and a deep practical understanding of medical device safety standards particularly IEC 60601-1 and its collateral standards. This critical role will not only be responsible for architecting and ensuring the electrical safety and performance of our advanced medical devices but also for translating complex technical concepts into clear understandable language for diverse audiences including clinical users regulatory bodies and internal stakeholders without an engineering background. The ideal candidate will be a strong technical leader and an outstanding communicator who can bridge the gap between highly technical engineering details and broader organizational understanding.
Essential Job Duties
System Architecture & Design (Hardware and System Focus)
- Lead the definition and decomposition of detailed system requirements ensuring traceability to user needs product specifications and global regulatory standards.
- Architect and optimize electrical systems including power distribution signal integrity sensor interfaces control systems and user interface elements in close collaboration with mechanical software and clinical engineering teams.
- Drive robust design decisions that balance performance reliability cost manufacturability and long-term serviceability.
Technical Communication & Explanation
- Articulate highly technical electrical and safety concepts clearly and concisely to non-technical audiences including marketing sales clinical specialists regulatory affairs and senior management.
- Develop simplified explanations diagrams and presentations to convey complex electrical design rationale safety measures and compliance strategies.
- Represent the engineering team in cross-functional meetings regulatory audits and discussions with external partners ensuring transparent and understandable communication.
- Prepare clear and compelling technical reports white papers and documentation that can be understood by various stakeholders.
IEC 60601-1 Compliance & Electrical Safety SME
- Act as the companys leading subject matter expert (SME) on IEC 60601-1 (General requirements for basic safety and essential performance of medical electrical equipment) and its associated collateral standards (e.g. IECfor EMC IECfor Usability and other particular standards).
- Proactively embed IEC 60601-1 compliance into electrical designs from the earliest concept stages through to final product verification.
- Define oversee and interpret results from electrical safety testing protocols (e.g. leakage current dielectric strength protective earthing creepage and clearance distances insulation coordination).
- Collaborate with external test houses and Notified Bodies to facilitate smooth safety and EMC testing for global product certifications.
- Develop and maintain comprehensive documentation including technical reports compliance matrices and risk management files (per ISO 14971) related to electrical safety.
Cross-Functional Leadership & Mentorship:
- Act as a key technical leader fostering strong collaboration across all engineering disciplines and functional groups (Quality Regulatory Manufacturing Clinical).
- Mentor and provide technical guidance to junior electrical and systems engineers promoting best practices in design safety and documentation.
Continuous Learning & Improvement:
- Maintain up-to-date knowledge of evolving medical device regulations industry standards (especially for electrical safety and EMC) and emerging systems engineering technologies.
- Proactively identify and champion opportunities for process improvement within the systems and hardware engineering functions.
Qualifications :
Required Education Skills and Experience
- Bachelors or Masters degree in Electrical Engineering Biomedical Engineering or a closely related field.
- Minimum of 7 years of progressive experience in electrical engineering within the medical device industry with at least 3 years in a senior or lead systems engineering role.
- Demonstrated expert-level knowledge of IEC 60601-1 (including Amendment 2) and its relevant collateral standards (e.g. IEC).
- Proven experience in applying ISO 14971 (Risk Management for Medical Devices) principles to hardware design and safety.
- Strong proficiency in analog and digital circuit design power supply design (AC-DC DC-DC) sensor integration and signal conditioning for patient-facing applications.
- Hands-on experience with schematic capture and PCB layout tools (e.g. Altium Designer OrCAD Cadence).
- Expertise with electrical test and measurement equipment (oscilloscopes multimeters power analyzers hipot testers leakage current testers spectrum analyzers etc.).
- Excellent understanding of electromagnetic compatibility (EMC) design principles and experience with EMC testing for medical devices.
- Familiarity with medical device quality management systems (e.g. ISO 13485 FDA QSR).
- Exceptional written and verbal communication skills with a proven ability to distill complex technical information into clear actionable insights for non-technical audiences. This includes strong presentation skills.
- Superior problem-solving analytical and critical thinking abilities.
Preferred Skills and Experience
- Experience with high-voltage and high-power electrical systems in medical devices.
- Understanding of embedded systems and firmware development lifecycle (e.g. IEC 62304).
- Experience in conducting or supporting root cause analysis (RCA) investigations related to electrical failures.
- Prior involvement in successful regulatory submissions (e.g. 510(k) CE Mark) and direct interaction with regulatory agencies.
Additional Information :
Due to the nature of our business and the role please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.
Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.
Mandatory Notices
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Preference will be given to qualified candidates who do not reside or plan to reside in Alabama Arkansas Delaware Florida Indiana Iowa Louisiana Maryland Mississippi Missouri Oklahoma Pennsylvania South Carolina or Tennessee.
We provide market-competitive compensation packages inclusive of base pay incentives benefits and equity. It would not be typical for someone to be hired at the top end of range for the role as actual pay will be determined based on several factors including experience skills and qualifications. The target compensation ranges are listed.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
