Clinical R&D Engineer
Location: Los Angeles, CA or St. Paul, MN or Target LA or Sylmar CA or Santa Clara CA or Minneapolis MN
Job Type: Long Term Contract
Industry: Medical Device / Healthcare Technology
Job Summary
Our client is seeking an experienced Clinical R&D Engineer to support the development and clinical evaluation of a new software release planned for deployment by the end of the year. Clinical trials are scheduled to begin in early October.
The ideal candidate must have hands-on experience developing clinical evaluation protocols and authoring Clinical Evaluation Reports (CERs). Strong knowledge of structural heart procedures, cardiac imaging, and clinical workflows is required.
Required Clinical Expertise
- Structural Heart procedures
- TAVR – Transcatheter Aortic Valve Replacement
- TMVR – Transcatheter Mitral Valve Replacement
- TTVR – Transcatheter Tricuspid Valve Replacement
- Cardiac CT planning
- LVOT assessment
- Cardiac imaging workflows
Required Qualifications
- Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Biological Sciences, Physical Sciences, or a related discipline.
- 6+ years of relevant experience in medical product development or an equivalent combination of graduate education and relevant project experience.
- Hands-on experience developing clinical evaluation protocols.
- Proven experience authoring Clinical Evaluation Reports (CERs).
- Experience applying clinical knowledge to product development and resolving project-related issues.
- Ability to integrate information across Clinical Affairs, Engineering, Marketing, and Regulatory Affairs.
- Experience working in a medical device, healthcare technology, or related regulated environment.
Key Responsibilities
- Investigate and define clinical requirements for new products and software features.
- Translate clinical requirements into product development projects through clinical review and evaluation.
- Work with field and medical personnel to establish benchmarks for evaluating clinical performance.
- Simulate and test aspects of new projects to evaluate prototypes and validate outputs against intended-use requirements.
- Analyze data collected from field activities and research studies.
- Develop and direct preclinical evaluation protocols, data analysis, and reports.
- Support feasibility studies, usability and human factors analyses, technology assessments, concept studies, benchmarking studies, and submission studies.
- Contribute to evaluation and validation activities for assigned systems and projects.
- Provide input to the Risk Management File and Clinical Evaluation Reports throughout the product lifecycle.
- Collaborate with Clinical Affairs, Engineering, Marketing, Regulatory Affairs, field personnel, and medical experts.
- Support clinical evaluation activities related to new software releases and clinical trials.
- Ensure compliance with FDA regulations, applicable regulatory requirements, company policies, procedures, and processes.
- Maintain effective communication and collaboration with employees, customers, contractors, vendors, and cross-functional stakeholders.
- Perform other related duties and responsibilities as assigned.
Ideal Candidate
The ideal candidate is a Clinical R&D / Medical Device Engineer with strong clinical evaluation experience and a proven background in clinical protocol development and CER authoring.
Candidates with hands-on experience in structural heart, TAVR, TMVR, TTVR, cardiac CT planning, LVOT assessment, and cardiac imaging workflows will be highly preferred.
Preferred Target Locations: Los Angeles, CA and St. Paul/Minneapolis, MN. Candidates in surrounding areas may also be considered.
Pay: $75.11 - $75.75 per hour
Experience:
- Clinical R&D: 1 year (Required)
- TAVR, TMVR, and/or TTVR: 1 year (Required)
- Cardiac CT planning: 1 year (Required)
- Clinical Evaluation Protocol development: 1 year (Required)
Location:
- Santa Clara, CA 95055 (Required)
Work Location: Hybrid remote in Santa Clara, CA 95055
