What are the responsibilities and job description for the R&D Engineer position at TekOne IT Services Pvt. Ltd.?
Title: R&D Engineer
Location: Danvers, MA (Onsite)
Job Description
Location: Danvers, MA (Onsite)
Job Description
- Design and develop test methods to support additional studies.
- Apply engineering principles for product design analysis and assessment.
- Prepare engineering reports to support domestic and international regulatory submissions.
- Conduct complaint evaluations and CAPA investigations to analyze potential device failures.
- Create and maintain technical documentation, including design history files, drawings, bills of materials, test protocols, reports, and engineering change orders.
- Coordinate and lead competitive testing and aging studies.
- Collaborate with physicians for product demonstrations.
- Optimize and refine existing products for improved performance.
- Develop expertise in endovascular procedures and integrate that knowledge into product development and risk assessments.
- Provide guidance to technicians and pilot associates.
- Identify issues and recommend practical solutions.
- Experience with process improvement methodologies (e.g., Lean, Hoshin, or Six Sigma).
- Strong knowledge of Quality System Regulations (ISO 9001, ISO 13485, 21 CFR Part 803, 806, & 820) and medical device process requirements.
- Master’s degree in science, engineering, or a related field; PMP certification preferred.
