SS
Clinical R&D Engineer
Sunrise Systems Inc
🌏 Worldwide
Remote
1 month ago
- Risk Management
- ACA
1 month ago
Not enough detail in this posting to match
Location: Remote
Duration: 6 Months of Contract
Description:
Desired Skillset:
- BS Degree in biomedical, mechanical, electrical, biological or physical science.
- Minimum of 6 years of relevant work of relevant work experience in medical product development and/or an equivalent combination of a graduate degree with relevant project experience.
- 3Demonstrated ability to apply understanding of clinical application to issues in order to bring tasks to resolution within assigned projects.
- Demonstrated ability to effectively integrate information from varied disciplines including Clinical Affairs, Engineering, Marketing and Regulatory Affairs
Responsibilities:
- Investigates and defines clinical requirements for new product/feature development and facilitates the translation into new projects through clinical review and evaluation.
- Works with field and medical personnel to define the benchmarks for evaluating the clinical performance of these products/features.
- Simulates or tests aspects of new projects to evaluate prototypes and validate output as meeting customers' intended use requirements; analyzes data collected from the field or from research studies.
- Develops and directs preclinical evaluation protocols, data analysis, and reports
- Contributes to the evaluation and validation of a specific system or project as necessary to conduct feasibility studies, usability and human factors analyses, technology assessments, concept studies, benchmarking studies, or submission studies.
- Provides input to the risk management file and Clinical Evaluation Reports in support of the product throughout its lifecycle.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Performs other related duties and responsibilities, on occasion, as assigned.
Compensation:
The hourly rate for this position is between $XX-XX per hour.
Factors which may affect starting pay within this range may include [geography/market, skills, education, experience and other qualifications of the successful candidate].
Benefits:
Sunrise offers ACA compliant medical coverage/dental insurance/vision insurance to all employees. We also offer Sick time benefits as required per State regulations.
Contact:
Jaya Balaji: jayabalaji.s@sunrisesys.com | (732) 515-5373 | URL: www.sunrisesys.com
Clinical R&D Engineer · Sunrise Systems Inc