Job Information
Sutter Health Manager, Medical Device Integration in San Francisco, California
Organization:
SHSO-Sutter Health System Office-Bay
Position Overview:
Manages the overall organization and structure to support the definition and implementation of service management methodology focusing on medical equipment standards and practices to spearhead the design, manufacturing, and distribution of cutting-edge consumer health devices and hospital-focused technologies, in line with our strategic digital health initiatives.
Primary functions include, data security definition and oversight, Regulatory compliance, enterprise system architecture definition and standardization. Responsible for leading technology integration projects designed to improve the clinical, operational, administrative, and long-term growth initiatives across Sutter affiliates and foundations through steering complex product development cycles from initial concept through to successful market launch. Will lead interdisciplinary teams to ensure that all products meet stringent quality standards and align with user expectations and needs. When FDA approval is required, will efficiently manage, and accelerate the regulatory submission process, maintaining strict compliance with all federal regulations.
Collaborates with management to identify organizational strategic capability needs and establish comprehensive action plans to address gaps and enable successful execution of medical device integration and technology advancement including testing, release management, enterprise architecture and environment functions across the enterprise. As a vital link between technical teams and executive leadership, this role is instrumental in transforming innovative medical device concepts into practical, market-ready solutions that advance healthcare.
Job Description :
EDUCATION:
- Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related field
EXPERIENCE
3 years of leadership experience in medical device development or related fields, with a significant emphasis on managing the full lifecycle of medical device innovation and manufacturing.
Proven track record in successfully navigating the FDA regulatory approval process for medical devices, including experience with 510(k) submissions, PMA applications, and compliance with ISO 13485.
SKILLS AND KNOWLEDGE:
Medical Device Standards and Regulations: Deep understanding of global and national regulatory requirements for medical devices, including FDA regulations, EU MDR, and ISO 13485, essential for ensuring compliance and guiding the regulatory submission process.
Biomedical Engineering Principles: Profound knowledge of biomedical engineering practices, including design, prototyping, and testing of medical devices, essential for developing innovative and safe products.
Material Science and Biocompatibility: Awareness of materials used in medical devices, their properties, and biocompatibility, critical for device safety and functionality.
Digital Health Technologies: Understanding of the integration of digital health solutions, such as IoT, wearable technologies, and mobile health applications, with traditional medical devices to enhance patient monitoring and outcomes.
Clinical Trials and Research Methodologies: Comprehensive knowledge of clinical trial design and execution, necessary for validating the efficacy and safety of new medical devices before market launch.
Clinical technology management as seen in, operations leadership experience preference towards area manager, region leadership etc.
Healthcare medical equipment network integration management experience.
Extensive work experience in project management methods and techniques, including risk and issue evaluation, and development and implementation of sophisticated project work plans.
Demonstrated past experience in managing project portfolios and programs as well as the formulation and execution of successful work teams and projects.
Significant experience using project management tools such as Microsoft project and resource tracking and documentation systems.
Strategic Leadership: Demonstrated ability to lead and inspire cross-functional teams, driving innovation and operational excellence in medical device development, with a proven record of delivering products that align with the organization's strategic objectives.
Analytical Problem Solving: Strong analytical and critical thinking abilities, adept at identifying, dissecting, and resolving complex technical and regulatory challenges through innovative solutions.
Adaptability and Continuous Learning: Commitment to continuous professional development in the rapidly evolving fields of medical technology and regulatory standards, coupled with the flexibility to adapt strategies in response to changing market and regulatory landscapes.
Innovation: Capacity to foster an environment of creativity and innovation, identifying new opportunities for device improvement and market differentiation.
Communication and Collaboration: Excellent interpersonal and communication skills, capable of effectively engaging and influencing stakeholders at all levels, including regulatory bodies, manufacturing partners, and healthcare providers, to ensure alignment and facilitate project success.
Project Management: Exceptional project management skills, with the ability to oversee complex projects from concept through to market launch, ensuring that timelines, budget constraints, and regulatory requirements are met or exceeded.
Effective written and oral presentation skills
Broad understanding of the Sutter Health Business (goals, strategies and objectives) as well as the Sutter HealthLandscape(Acute,AmbulatoryAffiliates) Financial skills
Demonstrated ability to complete work assignments with minimal direction and supervision and prioritization of multiple projects and information requests
FINANCIAL SKILLS:
Demonstrated ability to complete work assignments with minimal direction and supervision
Prioritization of multiple projects and information requests leadership skills
Ability to drive adoption and change in the organization
Management capabilities to establish and direct team as well as develop culture of accountability and discipline
Ability to understand Sutter specific business and technical context of changes
Ability to effectively coordinate, market and develop relationships with end-users, business/IT leadership and vendors
Program management, issue identification and resolution skills
Demonstrated ability to work collaboratively within a multi-discipline, multi-organizational project teamob Requirements (https://sutterhealth.sharepoint.com/:b:/s/JobAnalysisLibrary/ETcsrLLlDj5MlmKbw2ZsPB4BlHLH2296OimmwO58T7i_Ig?e=4cI5mO)
Job Shift :
Days
Schedule :
Full Time
Shift Hours:
8
Days of the Week:
Monday - Friday
Weekend Requirements:
As Needed
Benefits:
Yes
Unions:
No
This position is work from home eligible.
Position Status:
Exempt
Weekly Hours:
40
Employee Status:
Regular
Number of Openings:
1
Sutter Health is an equal opportunity employer EOE/M/F/Disability/Veterans.
Pay Range is $71.53 to $107.29 / hour
The salary range for this role may vary above or below the posted range as determined by location. This range has not been adjusted for any specific geographic differential applicable by area where the position may be filled. Compensation takes into account several factors including but not limited to a candidate’s experience, education, skills, licensure and certifications, department equity, training and organizational needs. Base pay is just one piece of the total rewards program offered by Sutter Health. Eligible roles also qualify for a comprehensive benefits package.
All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, marital status, sexual orientation, registered domestic partner status, sex, gender, gender identity or expression, ancestry, national origin (including possession of a driver's license issued to individuals who did not present proof of authorized presence in the U.S.), age, medical condition, physical or mental disability, military or protected veteran status, political affiliation, pregnancy or perceived pregnancy, childbirth, breastfeeding or related medical condition, genetic information or any other characteristic made unlawful by local, state, or federal law, ordinance or regulation. External hires must pass a background check/drug screening. 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.