You are responsible for:
• Overall technical responsibility and project leadership for realization of new product releases and sustaining activities.
• 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 Philips-Invivo through- innovation and design, while delivering high quality engineering solutions.
• Technical liaison to the program
• Defect/Risk management and Design Reviews
You are a part of:
A team of highly skilled engineers, focused on creating world-class health care solutions. Our focus on improving lives contributes to our amazing work environment and culture.
To succeed in this role, you should have the following skills and experience:
- Minimum of-BS Degree in Engineering- Electrical, Biomedical, Computer, Systems
- 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
- Minimum 5+ years engineering / R&D experience in a rigorous quality-focused environment
- Minimum 3+ years' experience in a Systems Engineering role, or a role having overall systems responsibility focused in systems/embedded software, firmware, as well as-electrical (analog and digital) and mechanical.
- Excellent requirements and specification writing skills
- Knowledge of product development processes and best practices
- Knowledge of verification and validation testing processes
- 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
- Knowledge performing risk management per ISO 14971
- Understanding of US and international regulatory requirements for medical devices
- Experience developing reliability plans
- In depth knowledge in developing and testing products to IEC60601-1 Safety standard and IEC60601-1-2 EMC standard
- Software development experience