Company: | INTGRA LIFE SCIENCE |
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Job Role: | Biomedical Sustain Engineers (Medical Device- Product Development). |
Experience: | (1-3 years). |
Vacancy: | 10+ |
Qualification: | BE/B.Tech, ME/M.Tech, MBA |
Salary: | 1,92,000USD/year. |
Location: | NJ-Princeton, USA. |
Join us on Telegram | Click Here |
Apply Mode: | (Online) |
Deadline: | Not Mentioned |
Responsibilities:
Several skills and abilities are needed in order to successfully perform this job, including but not limited to:
- Knowledge of biomaterials, Design Controls, engineering principles, and the compliance process is needed to perform technical and product-sustaining activities.
- Using Design Controls principles, knowledge of new product development, and our internal procedures, perform basic remediation activities.
- Understanding and executing the necessary steps to qualify a material or new manufacturing process using Design Controls and internal procedures to ensure the safety and efficacy of the product and compliance with regulations.
- Examine the manufacturing of biomaterials and any proposed changes to fully understand the implications of a proposed process or material change on the safety and efficacy of the affected product.
- Develop new products and line extensions utilizing Design Controls and internal procedures.
- Utilizing product knowledge and scientific literature, provide technical support for product registrations.
- Assist in other sustaining activities necessary to ensure our products remain effective, safe, and in compliance with applicable regulations.
- The requirements listed below are representative of the knowledge, skills, and/or abilities required for this position:
- Engineering (Biomedical Engineering preferred) bachelor's degree, or the equivalent combination of education and experience in a related field
- Medical device industry experience, preferably as a sustaining engineer, of at least 3 years
- Prefer experience with the development or refinement of biological implantable materials or expertise with tissue-based technologies
- A thorough understanding of collagen-based membrane performance in soft tissues, such as xenografts, allografts, natural matrices, and regenerative tissue, is required.
- A demonstrated ability to define tests, produce protocols, verify/validate designs, and process validation tests
- Working knowledge of U.S. and International standards governing the design, development, testing, and manufacture of medical devices
- Experience/familiarity with U.S. FDA, GMP, and ISO requirements for the design, validation, manufacturing processes and assembly of medical components and devices
- The ability to travel up to 15%
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