Company:
Futran Tech Solutions Pvt. Ltd.
Location: Orlando
Closing Date: 22/10/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
Job Title: System Engineer
Location: Orlando, FL ( (Day one Onsite)
Essential Skill - Must Have: System Engineer with Electrical Background, Medical Device, Risk Assessment ISO 14971, IEC60601-1 Safety standard
Job Description:
Systems Engineering in the medical area is what is needed and experience with these specs:
Location: Orlando, FL ( (Day one Onsite)
Essential Skill - Must Have: System Engineer with Electrical Background, Medical Device, Risk Assessment ISO 14971, IEC60601-1 Safety standard
Job Description:
Systems Engineering in the medical area is what is needed and experience with these specs:
- In depth knowledge performing risk management per ISO 14971
- In depth knowledge in developing and testing products to IEC60601-1 Safety standard
- In depth knowledge in developing and testing products to IEC62336 EMC standard
- Experience with deriving and simulating human interactions with devices and device use conditions
- Experience with electronic requirement data management SW - preferably DOORS
- Minimum five years engineering / R&D experience in a rigorous quality-focused environment
- DOORS and experience writing, reviewing requirements.
- Be a key contributor in the design and development of the Philips Clinical Applications and Devices Organization which includes MR Patient care a market leader in MR patient monitors which are the chosen solutions for the top 10 children's hospitals in the U.S.
- Overall technical leadership and responsibility for realization of a new product release and sustaining activity.
- Translation of user requirements, requirements management, top-level design, feasibility of potential solutions, decomposition of derived requirements
- Systems design/architecture and Integration oversight.
- Support for NPI efforts that create value for Clinical Applications and Devices Organization through innovation and design, while delivering high quality engineering solutions.
- Technical liaison to the program
- Defect/Risk management and Design Reviews
- A team of highly skilled engineers that is focused on creating world class health care solutions. Our focus on improving lives contributes to our amazing work environment and culture.
- BS degree in electrical engineering
- Experience leading medical, or other regulated industry, product development
- Experience in leading groups to solutions for complex problems
- Experience with deriving and simulating human interactions with devices and device use conditions
- Experience with electronic requirement data management SW - preferably DOORS
- Minimum five years engineering / R&D experience in a rigorous quality-focused environment
- Minimum three years' experience in a Systems Engineering role, or a role having overall systems responsibility involving electrical (analog and digital), mechanical, firmware and software development disciplines
- Excellent requirements and specification writing skills
- Demonstrated deep understanding of US and international regulatory requirements for a heavily regulated product
- Ability to build and maintain effective cross-functional and cross-organizational relationships
- Excellent oral, written and presentation skills
- In depth knowledge performing risk management per ISO 14971
- In depth knowledge in developing and testing products to IEC60601-1 Safety standard
- In depth knowledge in developing and testing products to IEC62336 EMC standard
- Understanding of US and international regulatory requirements for medical devices strongly preferred
- Experience developing reliability plans
- Knowledge of product development processes and best practices
- Knowledge of verification and validation testing processes
- Electrical or Software development experience is a plus
- Master's degree preferred
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Futran Tech Solutions Pvt. Ltd.
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