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- Redmond, WA 98052
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Modis • Redmond, WA
Posted 2 months ago
Job Description /Information:
• Provide engineering and clinical expertise in support of the design, development, manufacture and clinical application of Advanced Life Support (ALS) and Basic Life Support (BLS) products and accessories.
• Provide engineering and clinical support and advocate for the needs of the user and patient to ensure promotion of safe and effective products.
• Provide engineering and clinical expertise to produce required clinical deliverables for the EU MDR project
• Remediation of Clinical Evaluation Reports to meet EU Medical Device Regulation.
• Conducts medical literature searches and review; analyze field data for use in creation or revision of Clinical Evaluation Reports.
• Create and revise exiting clinical study protocols to meet product development and project needs.
• Develop proficiency in quality system procedures and medical device standards for compliance with class III medical device regulation
• Develop and share knowledge and expertise in technical aspects of physiologic monitoring parameters
• Conduct research collaboratively with scientists, clinical specialists and human factors engineers.
• Conduct clinical investigations in house and in the field
• Collaborate with cross-functional teams in area of systems, compliance, regulatory, quality and project engineering.
• Perform other related duties as assigned.
• Bachelor’s degree in biomedical engineering or other relevant engineering discipline
• Minimum 3 years’ experience working with medical devices or conducting biomedical research.
• Knowledge and experience with the Medical Device Directives, MEDDEV 2.7/1 revision 4 and EU Medical Device Regulation.
• Excellent organizational, interpersonal, negotiation and analytical skills.
• Excellent verbal communication skills.
• Demonstrated skills in critical care monitoring techniques? ECG rhythm interpretation skills.
• Ability to compose and edit technical and clinical documents for regulatory
• Strong time management skills, including the ability to handle multiple assignments.
• Excellent organizational, interpersonal and analytical skills