Biomedical Engineer
Wismed
Nơi làm việc
Durban
Hình thức tuyển dụng
Toàn thời gian
Chi tiết công việc
Medical Device company in Durban, South Arica is seeking an experienced Biomedical Engineer to join the team.
Purpose of the position
The engineer will primarily be involved in existing and new product research, design and development, and associated projects in the medical device industry in endourology and minimally invasive surgical technology
Key Roles and Responsibilities
• Support systems development including prototyping, testing, manufacturing, verification, validation, design transfer and associated metrics
• Participates in all aspects of the design process, including developing design specifications, mitigating product risks, and building the engineering design history file
• Build simulations and models of product functions and expected performance to conduct robust feasibility studies
• Write and execute engineering test strategies to perform successful product verification and validation of medical device products
• Participates in development risk assessments
• Supports the preparation of additional data/information requested by regulatory department
• Provide technical assessment, consultation, and opinion for medical devices development issues and impact of any planned changes to products
• Participates in the development, review, and release of product documents
• Assisting Manufacturing by developing process descriptions, maintenance procedures, and training applicable to manufacturing staff as needed
• Participate in performance improvement activities, utilize resources efficiently, and effectively
• Be aware of and comply with regulatory requirements that are applicable to the company, including but not limited to the MDR, ISO 13485, FDA
Qualifications and experience required:
• Bachelor’s Degree Mechanical or Biomedical engineering preferred or equivalent experience within the Medical Device industry
• Previous experience in Medical Devices
• Must be proficient in general computer programs such as Microsoft Office and CAD software
• Ability to understand and create engineering schematics and drawings
• Experience working in a QMS environment preferred
• Familiarity with production standards is preferred such as ISO 9000, ISO 14971, ISO 13485, and FDA 21 CFR 820
• Experience with standard business software.
• Background in human anatomy / biology strongly preferred
Knowledge and Skills Required
• Strong engineering knowledge and skills
• Strong planning, technical, and problem-solving skills
• Must have strong understanding of engineering level mathematics and physics
• Ability to prioritize and multi-task with little supervision
• Good experience with a computer aided design package (CAD or SolidWorks)
• Ability to work well in a team and efficiently within a highly regulated environment
• Excellent report-writing and communication skills
If you have not heard from us withing 2 weeks, please consider your application as unsuccessful
