Clinical Systems Engineer V - Regulatory Compliance & Patient Safety

Kaiser Permanente; Oakland (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

KAISER PERMANENTE in Oakland, California, seeks a Clinical Systems Engineer V focused on Regulatory Compliance and Patient Safety to lead validation, testing, and compliance for clinical technologies across care settings.

You will oversee medical equipment planning, vendor and incident investigations, and collaboration with clinical leaders to ensure alignment with FDA standards and enterprise cybersecurity requirements.

Qualifications

• Minimum one year of experience managing operational or project budgets.
• Minimum three years in a leadership role with or without direct reports.
• Minimum of three years of experience in project management.
• Bachelor's degree in engineering or related field or equivalent experience as stated above.

Responsibilities

• Promotes learning and collaboration across cross-functional teams to move projects forward.
• Oversees complex or large-scale healthcare technology assessments and site planning.
• Leads clinical systems deployment with equipment configurations and environment requirements.
• Ensures compliance with government regulations, accreditation, and industry standards.
• Performs technical testing on clinical systems and supports incident investigations.

Skills

Ambiguity management

Attention to detail

Business knowledge

Communication

Critical thinking

Cross-functional collaboration

Decision making

Dependability

Diversity & Inclusion

Drives results

Facilitation skills

Health care industry

Influencing others

Integrity

Learning agility

Organizational savvy

Problem solving

Teamwork

Topic-specific communication

Education

Bachelor's degree in engineering (Biomedical, Clinical, Mechanical, Electrical) or related field

Job description

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.

COMPANY: KAISER

TITLE: Clinical Systems Engineer V - Regulatory Compliance & Patient Safety

LOCATION: Oakland, California

REQNUMBER: 1446801

External hires must pass a background check/drug screen. Qualified applicants with arrest and/or conviction records will be considered for employment in a manner consistent with Federal, state and local laws, including but not limited to the San Francisco Fair Chance Ordinance. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, protected veteran, or disability status.