•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.
Minimum Qualifications / BASIC QUALIFICATIONS:
•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