Clinical Product Surveillance Specialist

General Electric Milwaukee , WI 53201

Posted 2 weeks ago

Clinical Product Surveillance Specialist

  • GE Healthcare

  • Experienced

  • Posted 3/8/2019 3:52:48 AM

  • 3261575

  • Job Function: Quality

  • Business Segment: Healthcare Quality

Location(s): United States; Wisconsin; Milwaukee

Role Summary:

Uses knowledge of clinical workflow and product use in assessing incoming complaints and the hazards they may contain as well as assisting in determining postmarket reportability. Provides guidance to a cross-functional team on clinical scenarios and how to identify potentially hazardous situations in complaints.

Essential Responsibilities:

Evaluate complaints from patient safety perspective and identify complaints that require further evaluation under 21CFR part 803 (MDR)

Responsible for hazard evaluations

Participate in Risk Assessments

Ensure customer communications are created and issued; review customer responses for technical accuracy related to GE products

Follow-up with the end user / customer

Participate in complaint investigations, CAPA and proper complaint closure according to set criteria

Analyze data on patient safety and risk, ensuring compliance with applicable postmarket regulations

Manage risk by identifying product safety issues; triage complaints for further investigation


Bachelor's degree in medical science, heath sciences or healthcare related field and a minimum of 2 years of clinical experience;

OR high school diploma/equivalency degree plus a minimum of 6 years of clinical experience

Desired Characteristics:

Product-specific knowledge

Registered Nurse or CRNA or Registered Radiologic Technologist

Demonstrated knowledge of 21CFR Part 820

Ability to demonstrate GEHC Growth Values

Understanding of the clinical environment and product work flow

Demonstrated experience prioritizing conflicting demands in an extremely fast paced environment

Ability to work independently & in a team setting

Excellent verbal, written, and presentation skills with the ability to communicate business issues clearly in English (and where appropriate, be able to communicate in the local language verbally and in writing).

Excellent interpersonal, organizational, and influencing skills

Familiarity with the application of medical device as it relates to patient safety11. Ability to analyze and process data, and draw the appropriate conclusions12.

Experience working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems13. Ability to analyze and process data, and draw the appropriate conclusions14. Prior experience working with Microsoft Office products15. Working knowledge of GEHC products

About Us:

GE Healthcare provides transformational medical

technologies and services to meet the demand for increased access, enhanced quality and more affordable

healthcare around the world. GE works on things that matter - great people and technologies taking on tough

challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery,

biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps

medical professionals deliver great healthcare to their patients.

target="_blank">Learn More About Careers at GE

Learn More About GE


GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status or any other characteristics protected by law.

Locations: United States; Wisconsin; Milwaukee

GE will only employ those who are legally authorized to work in the United States for this opening.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Clinical Product Specialist Manager (West)

Medtronic Inc.

Posted 3 weeks ago

VIEW JOBS 3/4/2019 12:00:00 AM 2019-06-02T00:00 Careers that Change Lives The Practice Clinical Product Specialist (PCPS) Manager is a field-based position responsible for managing a team of 4-6 clinical specialists as well as the management of an assigned PCPS territory. As a manager, this position is responsible for achieving business results through others as well as developing and retaining their direct reports. As a PCPS, the position is responsible for implementing and training Medtronic GIH practice and potential customers on clinical indications and applications for the GIH product portfolio in partnership with sales. The PCPS will serve as the customer facing clinical product expert responsible for developing greater customer depth in both product and clinical understanding. The PCPS team may also be required to help support and launch other products that may be developed, sold or promoted by Medtronic GIH division in the practice setting. Additionally, the PCPS is required to continuously develop a greater depth of knowledge to serve as the clinical experts for the company. By doing so, the PCPS can convey this information in an effective manner to help support optimal utilization of the practice portfolio to the widest range of healthcare providers possible. A Day in the Life People Management * Set direction and manage activities, deliverables, and deadlines of direct reports to meet strategic business needs * Hold weekly one-on-ones with direct reports * Provide ongoing feedback to direct reports * Facilitate the Medtronic annual performance management process, including regular professional development conversations * Co-travel with direct reports to assess capabilities and provide feedback and coaching * Maintain a bench of future potential PCPS candidates * Adjust team resources to cover open territories * Collaborate with sales management to ensure alignment of teams * Any other actions required by management Clinical Education * Provide clinical product demonstration and clinical education to targeted accounts through 1:1 and group interactions to increase customers' understanding and proficiency of Medtronic GIH portfolio in the practice. Lead post-sales activities, including implementation, product education, in-servicing, and ongoing support for Medtronic GIH products. Planning & Execution * Support the sales strategy; working with sales team to achieve business plans and drive utilization of the products * Support sales team efforts in lead generation and pre-sale clinical evaluations and demonstrations of products to demonstrate clinical value in the practice setting * Support Marketing and sales by appropriately communicating customer feedback, field product performance and competitive intelligence, as required for current technologies and product launches * Partner with sales to bring awareness around customers who could benefit from extended coverage through service contracts/plans to new and existing hospital customers * Collaborate and share best practices and other key insights with other PCPSs to help support them, their regions, and maximize the entire team's effectiveness and efficiency as well as support and train newly hired PCPS team members Administrative * Through Sales Force. Com (SFDC) update account information regarding installation, in-service and training records, as per corporate guidelines and established standard operating procedures Other duties as assigned by Director to support the team MITG BUSINESS DESCRIPTION The Minimally Invasive Therapies Group (MITG) is part of Medtronic plc, the global leader in medical technology. We are committed to ongoing breakthrough developments in leading-edge technology, unrivaled service and support, and uncompromising leadership. From advanced energy-based surgical devices to decades of experience across areas of respiratory care, we offer unmatched clinical and economic value through our range of market-leading brands. Our trusted technologies deliver performance and inspire confidence through a comprehensive approach that takes every element of a patient's health into careful consideration. Must Have: Minimum Requirements * Bachelors degree required * Minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience Nice to Have * Demonstrated ability to articulate highly technical information to a diverse audience * Ability to troubleshoot basic technical issues that may occur with any of Medtronic GIH Portfolio of products * Ability to establish and maintain good working relationships with all functional areas * Ability to multi-task and work independently * Good computer skills with specific skills in Microsoft Office: Power point, Excel, and Word * Management or supervisory experience * Professional education and training experience * Nursing degree or a certificate or license in the healthcare field * Experience working in GI and/or with physician practices * Demonstrated success in working in a team setting and matrix managed environment * Excellent interpersonal, written and verbal communication skills with individuals at all levels in business * Strong organization and time management skills * Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems * Usually in conjunction with an account manager, oversee successful execution of regional and local educational courses About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future. Physical Job Requirements The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. * While performing the duties of this job, the employee is regularly required to be independently mobile. * The employee is also required to interact with a computer and communicate with peers and co-workers. * Other examples: Able to lift 50 pounds, Able to view items through microscope, Extended periods of time doing computer-based work * Ability to travel overnight to client facilities by auto or aircraft 50-75% of the time including some weekend travel Ability to install equipment on-site. May be asked to set up exhibit displays at tradeshows. EEO STATEMENT: It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Medtronic Inc. Milwaukee WI

Clinical Product Surveillance Specialist

General Electric