Job Description
POSITION RESPONSIBILITIES:
- Collaborate in the Field Action/ recall processes ensuring field corrections are managed effectively and efficiently and reported to regulatory agencies as required
- Supervise Project Managers and Project Coordinators in the scheduling of repairs in the field
- Develop and prepare analytics and completion results to present for Agency update reports and communication to management
- Routinely communicate recall project goals, status, requirements, and deliverables to the Senior Program Manager
- Work with Marketing to define key customers and prioritize their execution. Manage communication with large key customers, IDN's, and health networks throughout their repair process
- Communicate with corporate and international regulatory professionals for execution outside of the US.
- Maintain Field Action Objective Evidence records in a categorized and easily accessible fashion. Contribute to audit preparedness and ensure accuracy and completeness of repair records and associated documentation.
- Strong customer centric communication skills required to support project completion with minimal Customer impact
- Computer skills: master level proficiency in MS Excel and MS Outlook expected
- Other duties as assigned by supervisor
- Work environment may be an office or home setting
MINIMUM QUALIFICATION, SKILL AND/OR COMPETENCY REQUIREMENTS
Education and Experience Required
Minimum 5 years Project Management experience required
University / College degree (BA) preferred
PMI Certification is a plus
Technical Knowledge and Skills
Position requires a significant amount of phone and email correspondence, strong verbal and written communication skills required
Experience in medical device industry is preferred
Excellent computer and data management skills required
Abilities
Strong analytical and problem-solving skills
Impact and Scope
Errors would result in additional time and cost to the company, as well as potential loss of customer accounts
Key Internal and External Relationships
All colleagues within Company including senior management
Contracted Field service engineers, Project Managers, and Data Entry Clerks
Customer representatives in Hospital Management including but not limited to Materials Management, Biomedical Engineering, and Clinical
Planning and Decision Making
Assist Senior Managers in their decisions by data preparation and analysis
Develop proposals with solid rationale
Supervision is available for escalated issues
About Us ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges.
With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings.
We're ready to bring you consistent quality, innovation, and value in more areas than ever. Our focus allows us to bring you:
- Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
- The industry's broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.
- IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.
- Significant US IV solutions manufacturing and supply capabilities.
This role is based remotely; the incumbent may be remote in any state other than Colorado; California; Connecticut; Montana, Maine or New York.
ICU Medical EEO Statement: ICU Medical is committed to fostering a diverse, inclusive, and equitable work environment. As an Affirmative Action and Equal Opportunity Employer, we ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender identity, gender expression, gender reassignment, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.
If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at humanresources@icumed.com. We are committed to providing equal access and opportunities for all candidates.
ICU Medical EEO Policy Statement
OFCCP Equal Opportunity Posters "Know Your Rights" Poster
Pay Transparency Nondiscrimination Provision
ICU Medical CCPA Notice to Job Applicants