1754-1 Project Engineer (San Rafael)

ABOUT TECHNICAL OPERATIONS:
- The Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

SUMMARY DESCRIPTION:
- The Medical Device and Combination Products Engineer (Sr Engineer 2 Level 8) is responsible for development of medical device components of drug-device combination products. Primary activity is to manage and support design control, risk management and human factor engineering. The Engineer will lead internal device teams and will represent the company to interact with technology and service providers, and contract manufacturers (CMOs) to ensure that all required activities are defined clearly and performed in a timely manner.

RESPONSIBILITIES:
- Drive device and combination product development related engineering activities on critical pipeline products. This includes component and sub-assembly design, creating design history files, and leading technical project team meetings.
- Create and own technical documentation (e.g. testing protocols, reports, SOPs, work instructions, etc.)
- Manage / support device development including regulatory activities.
- Support all regulatory filings and related activities.
- Manage / Support all stages of design control for class II/III medical devices.
- Interface with key stakeholders and outside experts / vendors to define project / product requirements to meet the company's Pipeline portfolio.
- Specify test requirements and acceptance criteria to satisfy quality and regulatory needs (e.g. Design Verification Testing, DVT).
- Lead / support risk analyses, such as hazard iden Postúlate en Kit Empleo: kitempleo.com.ar/empleo/pikx2