huMannity Medtec
This range is provided by huMannity Medtec. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$90,000.00/yr - $135,000.00/yr Summary
Responsibilities include the planning, conduct and interpretation of medical device pre-clinical/clinical research and Human Factors activities. This position plays a key role in the development and execution of pre-clinical, feasibility and first-in human trials intended to support regulatory registration of new indications and new medical devices, as well as physician-initiated and company sponsored, and grant funded clinical trials. Responsibilities
Handle/manage all duties related to the execution of US/OUS Class 3 Medical Device Clinical Trials in line with GCP, Regulatory and Compliance requirements. Drive study related activities from pre-clinical/clinical protocol design to Human Factors input, data management, study start-up/execution/close-out for one or several studies. Collaborate with SW and Systems Engineering on identifying and classifying issues reported during early research/engineering testing. Collaborate with other cross-functional teams (Quality, R&D, Regulatory, CROs, statisticians etc.). Train field clinical representatives and clinical sites on study protocols and investigational products. Collaborate on user requirements and design inputs. Conduct remote study monitoring and internal study audits. Provide back-up support for other projects on an as needed basis. Minimum Requirements
BS or MS degree in Engineering (Biomed, Mechanical, Electrical). 4+ years of experience in Clinical Trials with Class 3 medical devices. 3+ years of experience working in Industry. Excellent communication skills. Experienced with EDC systems and internal research tools to analyze clinical data. Experienced in collaborating with key opinion leaders and consultants. Experienced in collaborating with cross-functional teams (Quality, R&D, Regulatory, CROs, statisticians etc.). Experienced in maintaining a safe study environment by reporting Serious Adverse Events (SAEs), following organization standards and legal regulations. Proven track record of effectively working with clinical sites. Excellent writing skills. Experienced in independently writing protocols, reports of findings, publications, and other technical documents. Experienced in planning investigator meetings, Steering Committees Meetings, Events Adjudication Committees and DSMB meetings. Strong knowledge of clinical study guidelines (FDA, ICH and GCP) for Class III medical devices. SoCRA or ACRP Certification preferred. Ability to travel as required. A strong knowledge of neurostimulation applications in pre-clinical/cadaver studies is preferred. Skilled at designing experiments/studies, data collection and analysis, use of machine learning. Work Schedule
9/80 Work Week Seniority level
Mid-Senior level Employment type
Full-time Job function
Research, Analyst, and Information Technology Industry
Medical Equipment Manufacturing Referrals increase your chances of interviewing at huMannity Medtec by 2x Inferred from the description for this job Medical insurance Vision insurance 401(k) Disability insurance Get notified when a new job is posted. Sign in to set job alerts for “Clinical Engineer” roles. Santa Clarita, CA $120,000.00-$150,000.00 4 days ago Los Angeles, CA $112,000.00-$224,000.00 1 month ago Thousand Oaks, CA $33.33-$36.67 2 weeks ago Principal Field Clinical Engineer - Mountain West Santa Clarita, CA $103,700.00-$197,000.00 1 day ago Biomedical Technician- Applied Genomics, Computation & Translational Core Beverly Hills, CA $29.87-$46.30 2 weeks ago Staff Engineer, Bioinformatics Software Test Los Angeles, CA $103,100.00-$154,700.00 2 weeks ago Thousand Oaks, CA $36.00-$41.00 2 weeks ago
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$90,000.00/yr - $135,000.00/yr Summary
Responsibilities include the planning, conduct and interpretation of medical device pre-clinical/clinical research and Human Factors activities. This position plays a key role in the development and execution of pre-clinical, feasibility and first-in human trials intended to support regulatory registration of new indications and new medical devices, as well as physician-initiated and company sponsored, and grant funded clinical trials. Responsibilities
Handle/manage all duties related to the execution of US/OUS Class 3 Medical Device Clinical Trials in line with GCP, Regulatory and Compliance requirements. Drive study related activities from pre-clinical/clinical protocol design to Human Factors input, data management, study start-up/execution/close-out for one or several studies. Collaborate with SW and Systems Engineering on identifying and classifying issues reported during early research/engineering testing. Collaborate with other cross-functional teams (Quality, R&D, Regulatory, CROs, statisticians etc.). Train field clinical representatives and clinical sites on study protocols and investigational products. Collaborate on user requirements and design inputs. Conduct remote study monitoring and internal study audits. Provide back-up support for other projects on an as needed basis. Minimum Requirements
BS or MS degree in Engineering (Biomed, Mechanical, Electrical). 4+ years of experience in Clinical Trials with Class 3 medical devices. 3+ years of experience working in Industry. Excellent communication skills. Experienced with EDC systems and internal research tools to analyze clinical data. Experienced in collaborating with key opinion leaders and consultants. Experienced in collaborating with cross-functional teams (Quality, R&D, Regulatory, CROs, statisticians etc.). Experienced in maintaining a safe study environment by reporting Serious Adverse Events (SAEs), following organization standards and legal regulations. Proven track record of effectively working with clinical sites. Excellent writing skills. Experienced in independently writing protocols, reports of findings, publications, and other technical documents. Experienced in planning investigator meetings, Steering Committees Meetings, Events Adjudication Committees and DSMB meetings. Strong knowledge of clinical study guidelines (FDA, ICH and GCP) for Class III medical devices. SoCRA or ACRP Certification preferred. Ability to travel as required. A strong knowledge of neurostimulation applications in pre-clinical/cadaver studies is preferred. Skilled at designing experiments/studies, data collection and analysis, use of machine learning. Work Schedule
9/80 Work Week Seniority level
Mid-Senior level Employment type
Full-time Job function
Research, Analyst, and Information Technology Industry
Medical Equipment Manufacturing Referrals increase your chances of interviewing at huMannity Medtec by 2x Inferred from the description for this job Medical insurance Vision insurance 401(k) Disability insurance Get notified when a new job is posted. Sign in to set job alerts for “Clinical Engineer” roles. Santa Clarita, CA $120,000.00-$150,000.00 4 days ago Los Angeles, CA $112,000.00-$224,000.00 1 month ago Thousand Oaks, CA $33.33-$36.67 2 weeks ago Principal Field Clinical Engineer - Mountain West Santa Clarita, CA $103,700.00-$197,000.00 1 day ago Biomedical Technician- Applied Genomics, Computation & Translational Core Beverly Hills, CA $29.87-$46.30 2 weeks ago Staff Engineer, Bioinformatics Software Test Los Angeles, CA $103,100.00-$154,700.00 2 weeks ago Thousand Oaks, CA $36.00-$41.00 2 weeks ago
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