Job title: Medical Device BA – REMOTE WORK 57255
Company: Primus Global Services
Job description: We have an immediate long term opportunity with one of our key clients for a position of Medical Device BA, to work on a Remote basis.Responsibilities:
- Lead technical projects involving medical devices for major biotech companies such as Siemens, Roche, and BD.
- Act as the primary point of contact for medical device-related projects, ensuring alignment with business requirements and regulatory standards.
- Analyze and document business requirements, translating them into technical specifications for software and hardware integration.
- Manage the interface and integration of medical devices with HL7, ASTM, LIS/LIMS systems.
- Provide expert guidance on medical device software and hardware, ensuring compliance with industry standards and regulations.
- Conduct feasibility studies and risk assessments for new medical device projects.
- Develop and maintain project documentation, including requirements, design specifications, test plans, and user manuals.
Skills and Competencies:
- Extensive experience in medical devices, acting as a technical lead for major biotech companies such as Siemens, Roche, and BD.
- Deep understanding of medical device software and hardware.
- Proficient in interfacing medical devices with HL7, ASTM, LIS/LIMS systems.
- Strong ability to analyze and document business requirements and translate them into technical specifications.
- Proven experience managing technical projects in the biotech or medical device industry.
- Knowledge of industry standards and regulatory requirements for medical devices.
- Experience conducting feasibility studies and risk assessments for medical device projects.
- Validation and Testing: Experience supporting the validation and testing of medical device software and hardware.
For Immediate consideration, please contact:Shanmukh Reddy
PRIMUS Global Services
Direct – (972) 914 -2434
Desk- 972-753-6500 Ext: 205
Email:
Expected salary:
Location: San Jose, CA
Job date: Thu, 01 Aug 2024 22:40:03 GMT
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