The Product Development Engineer II will be responsible for the electrical and software aspects of a project, interacting with external design and development partners, participating on cross-functional project teams through all phases of the product development process, and assisting the technical team with planning, executing, documenting and communicating testing activities.
* Fulfill design control requirements including the creation of detailed electrical/software specifications and requirements, detailed design files, design verification and validation test plans, risk management, DHF, protocols, and reports in accordance with company procedures, FDA and ISO guidelines.
* Work with development partners and other external vendors to support project plan deliverables.
* Coordinate and participate in the development of electrical/software architectures for medical devices.
* Coordinate, review and approve electrical/software documentation created by external partners, including product requirements, schematics, code, verification and validation test protocols and reports.
* Prepare and lead Design Reviews, Technical Reviews, and Peer Reviews.
* Provide support for field-based Sales Team and other Commercial partners.
* Partner with Downstream Marketing, Sales and key external stakeholders to identify unmet clinical/surgical needs; evaluate options; and provide sound engineering solutions.
* Collaborate with internal and external partners to launch new products.
* Attend industry trade-shows, professional education events, and other company-sponsored events to provide product training and support to customers as needed.
Bachelor?s Degree in engineering is required, with preference for Electrical and Computer Engineering.
* Advanced Degree (MS) in Electrical Engineering, Computer Engineering, or equivalent is preferred.
* Black Belt certification is desired.
* A minimum of 5 years of engineering experience is required
* Majority of the experience encompasses of electrical design of low power devices and real-time software for embedded systems is required.
* Experience in medical device product development is preferred, with emphasis in hand held units, monitoring devices and/or neurosurgery field.
* Knowledge of medical device product development in a regulated environment (e.g., FDA, ISO) is required
* Experience with Electrical safety testing is required (i.e., 60601-1).
* Experience with Medical Software life cycle processes is required (i.e., 62304).
* Real-time embedded software experience is a plus (e.g., Java, C, C++, Linux OS, QNX OS).
* Experience with x86 or ARM microprocessors, PIC microcontroller, and CPLD firmware is a plus
* Knowledge of device drivers is a plus.
* Experience with electrical CAD tools including schematic capture, simulation and PCB layout is a plus.
* Experience with low power RF technologies and connectivity to smart devices is a plus.
* Demonstrated detailed design analysis and statistical analysis for a robust and manufacturable device is required.
* Ability to be both a strong team player as well as team leader is desired.
* Prior experience working with project teams bringing products from concept to launch is preferred.
* Strong communication skills are required; the ability to effectively communicate concepts, ideas and knowledge to other individuals, surgeons, customers and/ or teams.