Address Overview:
Qualifications:
OTHER WORK REQUIREMENTS:
The Clinical Validation Engineer serves multiple roles for the Spacelabs Patient Monitoring and Connectivity product line. The Marketing and Research and Development groups require a clinical voice of the customer based on personal experience as well as via our field-based clinicians and customers. This role requires collaboration with customers, product management, engineering, and clinical education consultants to release clinically safe and appropriate products. This role is highly involved in the definition, usability, and validation of our Patient Monitoring products, both present and future.
Responsibilities: - Participate in design reviews and provide clinical input and design recommendations
- Create plans, protocols, reports, that are in compliance with standards, regulatory requirements, and Spacelabs New Product Development process to document activities and release new products to market.
- Plan and execute design validation activities.
- Participate in product risk identification, analysis, and mitigation.
- Provide content for and review of instructions for use.
- Provide related clinical education to R&D and product management personnel.
- Stay current on industry practices.
- Uphold the Company’s core values of Integrity, Innovation, Accountability, and Teamwork.
- Demonstrate behavior consistent with the Company’s Code of Ethics and Conduct
- It is the responsibility of every Spacelabs Healthcare employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem.
- Duties may be modified or assigned at any time to meet the needs of the business.
Qualifications:
- Licensed clinician such as Registered Nurse.
- Bachelor’s degree in related field required. Masters’ degree a plus.
- 5+ years of experience working in a clinical environment and/or other relevant experience. 3+ years of that must be clinical experience in a critical care area such as ICU – with experience in the use of patient monitors and other patient care devices, and with ECG interpretation.
- Self-motivated and experienced being a team player.
- Experience owning significant areas of product validation and test environment, including definition and executions of design validation requirements.
- Medical device industry experience highly desired.
- Ability to manage multiple, complex priorities within demanding timeframes.
- Highly developed relationship-building skills, and strong presentation and communication skills.
- Experience working positively and productively in a team environment.
- Proficient with Microsoft Office PC and comfortable learning/using other PC based tools.
OTHER WORK REQUIREMENTS:
- May be required to register with a vendor credentialing service. As part of this process, s/he may be required to submit personal information to a credentialing service company, provide proof of vaccinations or related medical information, and comply with other requirements needed to be able to work at customer site.
