- Lead dedicated internal and US Clinicians test campaigns related to R&D prototypes
- Collaborate with cross-functional teams including regulatory affairs, quality assurance, and clinical operations to ensure alignment of clinical development plans with overall project goals
- Support the R&D design team, proposing under his/her responsibility user needs/specifications and product inputs; then independently or with the support of medical personnel define test protocols and test the system or its subparts simulating clinical use until validation of the expected performance as well as its safety, as well as the generation of detailed reports
- Define specific workflows and procedures for using the product that simplify and guide its best practices in the operating room by optimizing performance or resolving any possible limitations.
- Draft and keep aligned with the stage of product and project progress the technical documentation related to user aspects (e.g. User Manual, Use-Related Risk Analysis, Training Guide, Simulated Use, Human Factor Engineering, etc...)
- Support regulatory interactions, including preparation of submissions to regulatory agencies and responses to inquiries
- Identify and promote new and possible target clinical applications by characterizing the clinical procedure, analyzing available databases, attending specific conferences, performing demos, cadaver lab, or following real cases in the operating room
- Organize and execute pre-clinical tests/studies or test campaigns aimed at monitoring and quantifying specific clinical outcomes of the product; then collect and analyze technical and clinical data preparing comprehensive reports for internal review that could capture potential problems or inputs for improvement, regulatory submissions, and possibly support publication in scientific reports/journals
- Nurture and enhance relationships with key opinion leaders and members of the relevant microsurgical community in a relationship of esteem and respect, including possible support in the production of conference/congress material
- Master's degree in Biomedical Engineering or scientific degree with relevant experience
- 5 years as Clinical Development Engineer in Medical Device
- Experience in Surgical Robotics
- Experience in Medical Device simulated use and iterative technical development refinement process
- Experience running ex-vivo, cadaver or in-vivo tests
- Experience in training surgical staff and running Human Factors test studies
- Experience in approval and regulatory processes
- Ability to write technical and clinical documentation
- Knowledge of Anatomy and Physiology and ability to relate to medical personnel using appropriate medical and surgical vocabulary
- Live in the greater Jacksonville area
- Availability for global travel
-
Senior Clinical Engineer
3 weeks ago
TalentHubb Jacksonville, United StatesWe are seeking a highly skilled and experienced Senior Clinical Development Engineer to join our dynamic team. The Senior Clinical Development Engineer will play a crucial role in the research and development of medical devices, ensuring compliance with regulatory standards and u ...
-
Senior Clinical Development Engineer
2 days ago
Medical Microinstruments, Inc. Jacksonville, United StatesWant to join a motivated global team of 200+ people who are dedicated to improving patient care through surgical robotics? Interested in working in the fast-paced, medical device industry in a new and exciting field of robotic micro-surgery? Medical Microinstruments Inc is lookin ...
-
Senior Clinical Engineer
3 weeks ago
TalentHubb Jacksonville, United StatesWe are seeking a highly skilled and experienced Senior Clinical Development Engineer to join our dynamic team. The Senior Clinical Development Engineer will play a crucial role in the research and development of medical devices, ensuring compliance with regulatory standards and u ...
-
Senior Clinical Development Engineer
3 weeks ago
Medical Microinstruments, Inc. Jacksonville, United StatesWant to join a motivated global team of 200+ people who are dedicated to improving patient care through surgical robotics? Interested in working in the fast-paced, medical device industry in a new and exciting field of robotic micro-surgery? Medical Microinstruments Inc is lookin ...
-
Senior Clinical Development Engineer
3 weeks ago
Medical Microinstruments, Inc. Jacksonville, United StatesWant to join a motivated global team of 200+ people who are dedicated to improving patient care through surgical robotics? Interested in working in the fast-paced, medical device industry in a new and exciting field of robotic micro-surgery? Medical Microinstruments Inc is lookin ...
-
Sr. Clinical Development Engineer
3 weeks ago
Talenthubb Jacksonville, FL, United StatesWe are seeking a highly skilled and experienced Senior Clinical Development Engineer to join our dynamic team. The Senior Clinical Development Engineer will play a crucial role in the research and development of medical devices, ensuring compliance with regulatory standards and u ...
-
Medical Device Associate Clinical Engineer
4 weeks ago
Highlander Consultants Jacksonville, United StatesOur client, a global medical device firm, is seeking a couple of Associate Clinical / Planning Engineers for the Jacksonville Market: · Planning Engineer - Job Summary · The Planning position involves communicating technical information, simulating surgeries for the customer (sur ...
-
Sr. Clinical Developer
3 weeks ago
TekValue IT Solutions Jacksonville, United StatesJob Requirements: · Master's degree in Biomedical Engineering or scientific degree with relevant experience · 5 years as Clinical Development Engineer in Medical Device · Experience in Surgical Robotics · Experience in Medical Device simulated use and iterative technical deve ...
-
Ascension Jacksonville, United States Full time, Part timeAscension has provided thousands of associates and caregivers a rewarding career in healthcare since 1902. We strive to expand access to high-quality, low-cost, person-centered care and services for all. At AMG STV PODIATRY CLINIC, caregivers can find both a jumpstart to their ca ...
-
New CNAs
3 weeks ago
Ascension Jacksonville, United States Full time, Part timeAscension has provided thousands of associates and caregivers a rewarding career in healthcare since 1902. We strive to expand access to high-quality, low-cost, person-centered care and services for all. At St. Vincent's - Pain Pump Clinic, caregivers can find both a jumpstart to ...
-
New CNAs
4 weeks ago
Ascension Jacksonville, United States Full time, Part timeAscension has provided thousands of associates and caregivers a rewarding career in healthcare since 1902. We strive to expand access to high-quality, low-cost, person-centered care and services for all. At AMG SV NEUROSURGERY SOUTHSIDE, caregivers can find both a jumpstart to th ...
-
New CNAs
4 weeks ago
Ascension Jacksonville, United States Full time, Part timeAscension has provided thousands of associates and caregivers a rewarding career in healthcare since 1902. We strive to expand access to high-quality, low-cost, person-centered care and services for all. At Ascension St. Vincent's Primary Care Joe Adams FP, caregivers can find bo ...
-
New CNAs
3 weeks ago
Ascension Jacksonville, United States Full time, Part timeAscension has provided thousands of associates and caregivers a rewarding career in healthcare since 1902. We strive to expand access to high-quality, low-cost, person-centered care and services for all. At Primary Care - Ortega, caregivers can find both a jumpstart to their care ...
-
Ascension Jacksonville, United States Full time, Part timeAscension has provided thousands of associates and caregivers a rewarding career in healthcare since 1902. We strive to expand access to high-quality, low-cost, person-centered care and services for all. At Ascension St. Vincent's Primary Care, caregivers can find both a jumpstar ...
-
Ascension Jacksonville, United States Full time, Part timeAscension has provided thousands of associates and caregivers a rewarding career in healthcare since 1902. We strive to expand access to high-quality, low-cost, person-centered care and services for all. At Mandarin - Ascension St. Vincent's Health Center Pediatrics, caregivers c ...
-
Ascension Jacksonville, United States Full time, Part timeAscension has provided thousands of associates and caregivers a rewarding career in healthcare since 1902. We strive to expand access to high-quality, low-cost, person-centered care and services for all. At PHY MED AND REHAB, caregivers can find both a jumpstart to their careers ...
-
Ascension Jacksonville, United States Full time, Part timeAscension has provided thousands of associates and caregivers a rewarding career in healthcare since 1902. We strive to expand access to high-quality, low-cost, person-centered care and services for all. At St. Vincent's Transitional Care, caregivers can find both a jumpstart to ...
-
New CNAs
1 day ago
Ascension Jacksonville, United States Full time, Part timeAscension has provided thousands of associates and caregivers a rewarding career in healthcare since 1902. We strive to expand access to high-quality, low-cost, person-centered care and services for all. At St. Vincent's Rheumatology Riverside, caregivers can find both a jumpstar ...
-
New CNAs
4 weeks ago
Ascension Jacksonville, United States Full time, Part timeAscension has provided thousands of associates and caregivers a rewarding career in healthcare since 1902. We strive to expand access to high-quality, low-cost, person-centered care and services for all. At Jax Beach Primary Care, caregivers can find both a jumpstart to their car ...
-
Ascension Jacksonville, United States Full time, Part timeAscension has provided thousands of associates and caregivers a rewarding career in healthcare since 1902. We strive to expand access to high-quality, low-cost, person-centered care and services for all. At Ascension Medical Group St. Vincent's - Endocrinology, caregivers can fin ...
Senior Clinical Engineer - Jacksonville, United States - TalentHubb
Description
We are seeking a highly skilled and experienced Senior Clinical Development Engineer to join our dynamic team. The Senior Clinical Development Engineer will play a crucial role in the research and development of medical devices, ensuring compliance with regulatory standards and user/clinical requirements. This position requires strong analytical skills, excellent communication abilities, and a deep understanding of medical device development processes.
Role and main responsibilities:
Job Requirements:
Senior Clinical Engineer professionals in Jacksonville
-
Kanchana M
Java Spring & Webservices developer