Clinical Systems Engineer V - Regulatory Compliance & Patient Safety

The Clinical Systems Engineer V - Regulatory Compliance & Patient Safety will lead enterprise Healthcare Technology Management (HTM) regulatory compliance and medical device patient safety initiatives through complex or large-scale assessments, compliance surveillance, program governance, incident investigation, corrective action, and readiness planning. Serves as a senior functional and technical specialist responsible for translating regulatory, accreditation, manufacturer, organizational, and patient safety requirements into defensible enterprise policies, procedures, Business Process Packages (BPPs), audit tools, response playbooks, and operating expectations.
Drives conversations and influences stakeholders across organizational lines to align medical equipment management, risk identification, survey readiness, hazard and recall response, documentation, and continuous improvement practices. Partners with HTM leaders and field teams, Patient Care Services, Risk Management, Patient Safety, Legal, IT, Sourcing, Supply Chain, analytics teams, and other stakeholders to strengthen consistent execution across markets and facilities. Individual positions may be assigned primary responsibility for regulatory compliance and readiness or patient safety and incident response while supporting the full program scope.

Job Summary:
Performs healthcare technology strategy and planning for inpatient/outpatient healthcare delivery through complex or large-scale assessments, needs, and site planning, as well as implementing systems and through investment analyses. Drives conversations and influences clinical systems deployment and collaborates on incident investigations as needed. Provides healthcare technology expertise for testing clinical systems and equipment, resolving complex issues, and documenting overall process. Facilities planning for healthcare technology research and assesses new healthcare-related technologies across the market. Provides oversight for compliance/regulatory requirements across organizational lines through coordinating relevant processes and reviewing FDA and non-regulatory hazard alerts in a healthcare delivery setting. Develops, analyzes, and manages technology plans through a variety of program management methodologies within a market.

Essential Responsibilities:

• Promotes learning in others by communicating information and providing advice to drive projects forward; builds relationships with cross-functional stakeholders. Listens, responds to, seeks, and addresses performance feedback; provides actionable feedback to others, including upward feedback to leadership and mentors junior team members. Practices self-leadership; creates and executes plans to capitalize on strengths and improve opportunity areas; influences team members within assigned team or unit. Adapts to competing demands and new responsibilities; adapts to and learns from change, challenges, and feedback. Models team collaboration within and across teams.
• Conducts or oversees business-specific projects by applying deep expertise in subject area; promotes adherence to all procedures and policies. Partners internally and externally to make effective business decisions; determines and carries out processes and methodologies; solves complex problems; escalates high-priority issues or risks, as appropriate; monitors progress and results. Develops work plans to meet business priorities and deadlines; coordinates and delegates resources to accomplish organizational goals. Recognizes and capitalizes on improvement opportunities; evaluates recommendations made; influences the completion of project tasks by others.
• Leads clinical systems by: driving conversations and influencing user groups and strategic partners to align on equipment configurations, review facility construction plans and equipment lists, and provide technical or environment requirements for deployment of complex or large-scale projects; and collaborating on complex incident investigations and equipment performance analysis on complex problems to determine root causes of issues, develop solutions, and promote preventative measures to ensure a safe environment.
• Provides oversight for compliance by: coordinating with stakeholders across organizational lines to ensure systems and processes are used and maintained in a manner that ensures compliance with all relevant government regulations, accreditation, and industry standards; and performing initial inspection of new equipment purchases (e.g., testing to verify that equipment meets qualifications) for verification to develop or review project equipment lists for compliance with standards and budgetary guidelines.
• Provides technical expertise for clinical systems by: performing technical testing on a variety of clinical systems and associated equipment and technology; providing technical expertise for identifying, monitoring, and resolving complex issues related to clinical systems and healthcare technologies that present a risk to the enterprise; recording and maintaining documentation for design specifications, testing, and validating of new and innovative technology to be incorporated into the enterprise in alignment with standards and requirements; providing technical expertise and consult for operational impacts of existing and new systems and technologies, establishing timeframes, and prioritizing projects within market objectives; and driving cyber security trends in healthcare and ensure implementation within the enterprise in accordance with industry and company standards for healthcare technology.
• Executes strategies for clinical systems by: conducting complex or large-scale healthcare technology assessments, needs analysis, and site planning to identify and recommend appropriate healthcare technologies for implementation; assessing, designing and/or implementing complex systems that enable networking, integration, and interoperability of healthcare technologies within multiple care delivery settings; applying independent judgement when conducting complex cost-benefit analyses and driving recommendations; and consulting with senior leaders to gain buy-in and alignment in support of the development and production of healthcare technology forecasts, procurement programs, and service contracts for multiple care delivery settings and for the market.
• Facilitates innovative planning related to healthcare technologies by: researching and assessing new health care-related technologies, strategies and concepts, disseminating this information as appropriate across the enterprise and integrating them/updating healthcare technology program processes; and conducting research to stay abreast of cutting-edge technology, future roadmaps, and industry trends around products and services, and coordinating technology pilots (e.g., attending conferences or tradeshows, vendor product events).
• Develops, analyzes, and manages technology plans by: ensuring strategy and scope identification, managing schedules, evaluating inter-dependencies, and resource forecasting for a clinical portfolio within a market; and driving overall portfolio performance (e.g., on time, on budget, within scope, and with quality) against plan, ensuring measurement of business benefits and outcomes, and making adjustments as needed.

Knowledge, Skills and Abilities: (Core)

• Ambiguity/Uncertainty Management
• Attention to Detail
• Business Knowledge
• Communication
• Critical Thinking
• Cross-Group Collaboration
• Decision Making
• Dependability
• Diversity, Equity, and Inclusion Support
• Drives Results
• Facilitation Skills
• Health Care Industry
• Influencing Others
• Integrity
• Learning Agility
• Organizational Savvy
• Problem Solving
• Short- and Long-term Learning & Recall
• Teamwork
• Topic-Specific Communication

Knowledge, Skills and Abilities: (Functional)

• Business Acumen
• Compliance Management
• Computer Literacy
• Confidentiality
• Conflict Resolution
• Consulting
• Cost Optimization
• Engineering
• IT Standards, Procedures & Policies
• Medical Equipment
• Medical Equipment Planning
• Negotiation
• Project Management
• Quality Assurance Process
• Vendor Management

Minimum Qualifications:

• Minimum one (1) year of experience managing operational or project budgets.
• Minimum three (3) years of experience in a leadership role with or without direct reports.
• Minimum of three (3) years of experience in project management.
• Bachelors degree in engineering (Biomedical, Clinical, Mechanical, Electrical), engineering technology, or related field AND minimum five (5) years of experience in engineering or a directly related field OR Minimum eight (8) years of experience in engineering or a directly related field.

Preferred Qualifications:

• Certification in Clinical Engineering.
• Three (3) years of experience in a leadership role of a large matrixed organization.

Primary Location: California,Oakland,1800 Harrison Additional Locations:

• Denver, CO
• Portland, OR
• Atlanta, GA
• Pasadena, CA
• San Diego, CA
• Hyattsville, MD
• Renton, WA
• Sacramento, CA

Scheduled Weekly Hours: 40
Shift: Day
Workdays: Mon, Tue, Wed, Thu, Fri,
Working Hours Start: 08:00 AM
Working Hours End: 05:00 PM
Job Schedule: Full-time
Job Type: Standard
Employee Status: Regular
Worker Location: Flexible
Employee Group/Union Affiliation: NUE-PO-01|NUE|Non Union Employee
Job Level: Individual Contributor
Department: Oakland Reg - 1800 Harrison - National Clinical Technology - 0308
Pay Range: $146600 - $189640 / year Kaiser Permanente strives to offer a market competitive total rewards package and is committed to pay equity and transparency. The posted pay range is based on possible base salaries for the role and does not reflect the full value of our total rewards package. Actual base pay determined at offer will be based on labor market data, internal alignment, and a candidate's years of relevant work experience, education, certifications, skills, and geographic location.
Travel: Yes, 20 % of the Time